Mar 04 2020

What’s New Health Canada? January and February 2020 Updates

 

By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate

 

What’s New in:

 

 

Updates from Health Canada

 

Type of Update and Link Date Posted
Notice: Product Monograph Implementation Plans 13 January 2020
Notice: Implementation of eCTD for Clinical Trial Regulatory Activities 19 February 2020
Notice: Release of Draft Guidance Document for Consultation: Comparative Pharmacokinetic Studies for Orally Inhaled Products 26 February 2020

 

 

Santé Canada: Quoi de neuf?

Par Alejandra Gomez Perez. M.Sc., Associée, Affaires Réglamentaires

 

Quoi de neuf :

 

 

Mises à jour de Santé Canada

 

Genre de mise à jour et lien Date
Avis : Plans de mise en œuvre des monographies de produit 17 février 2020
Avis : Mise en œuvre du format eCTD pour les activités de réglementation des essais cliniques 19 février 2020
Avis : Publication de l’ébauche de la ligne directrice aux fins de consultation : Études pharmacocinétiques comparatives sur les produits administrés par inhalation orale 26 février 2020

Feb 04 2020

New FDA Gudiances for January 2020 and Upcoming Advisory Committee Meetings

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS

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Special Interest Guidances/Information Date Posted
Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry: Draft Guidance for Industry – Draft Guidance 30 Jan 2020
Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use – Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 28 Jan 2020
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry – Final Guidance 28 Jan 2020
Human Gene Therapy for Retinal Disorders: Guidance for Industry – Final Guidance 28 Jan 2020
Human Gene Therapy for Rare Diseases: Guidance for Industry – Final Guidance 28 Jan 2020
Human Gene Therapy for Hemophilia: Guidance for Industry – Final Guidance 28 Jan 2020
Long Term Follow-up After Administration of Human Gene Therapy Products: Guidance for Industry – Final Guidance 28 Jan 2020
Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up: Guidance for Industry – Final Guidance 28 Jan 2020
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations: Draft Guidance for Industry – Draft Guidance 27 Jan 2020
Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment: Guidance for Industry – Final Guidance 24 Jan 2020
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry: Guidance for Industry – Final Guidance 23 Jan 2020
Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry – Final Guidance 23 Jan 2020
In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry – Final Guidance 23 Jan 2020
Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff – Final Guidance 22 Jan 2020
Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry – Draft Guidance 22 Jan 2020
Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 Questions and Answers: Draft Guidance for Industry – Draft Guidance 15 Jan 2020
Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 13 Jan 2020
Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization: Guidance for Industry – Final Guidance 02 Jan 2020
 
Upcoming Meetings (* = New)
* February 26, 2020: Meeting of the Oncologic Drugs Advisory Committee Meeting
* March 4, 2020: Vaccines and Related Biological Products Advisory Committee Meeting

Last updated: 04 February 2020

Jan 06 2020

New FDA Guidances for November and December 2019 and Upcoming Advisory Committee Meetings

By Alice Li, MD, MSc, RAC(CAN), Regulatory Scientist, Cato Research

Special Interest Guidances/Information

Date Posted

Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics – Final Guidance

30 Dec 2019

Submission of Plans for Cigarette Packages and Cigarette Advertisements – Draft Guidance

27 Dec 2019

Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry – Draft Guidance

23 Dec 2019

Requesting FDA Feedback on Combination Products : Draft Guidance for Industry and FDA Staff – Draft Guidance

23 Dec 2019

Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry – Draft Guidance

20 Dec 2019

Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff – Final Guidance

20 Dec 2019

Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review: Guidance for Industry; Technical Specifications Document – Final Guidance

20 Dec 2019

Considerations for the Development of Dried Plasma Products Intended for Transfusion: Guidance for Industry – Final Guidance

19 Dec 2019

Bridging for Drug-Device and Biologic-Device Combination Products: Draft Guidance for Industry – Draft Guidance

18 Dec 2019

30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff – Final Guidance

16 Dec 2019

Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administration Staff – Final Guidance

16 Dec 2019

Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry and Food and Drug Administration Staff – Final Guidance

16 Dec 2019

eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff – Final Guidance

16 Dec 2019

FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff – Final Guidance

16 Dec 2019

Guidance for Industry: Nutrition and Supplement Facts Labels Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals – Final Guidance

16 Dec 2019

Real-Time Premarket Approval Application (PMA) Supplements: Guidance for Industry and FDA Staff – Final Guidance

16 Dec 2019

Chapter 2 – Biologics – Final Guidance

13 Dec 2019

Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff – Draft Guidance

13 Dec 2019

FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act: Draft Guidance for Industry – Final Guidance

12 Dec 2019

Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids Guidance for Industry: Draft Guidance for Industry – Draft Guidance

09 Dec 2019

Magnetic Resonance (MR) Coil – Performance Criteria for Safety and Performance Based Pathway: Draft Guidance for Industry and Food and Drug Administration Staff-Draft Guidance

09 Dec 2019

Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment Guidance for Industry: Draft Guidance for Industry-Draft Guidance

04 Dec 2019

Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry-Final Guidance

29 Nov 2019

Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products-Draft Guidance

27 Nov 2019

Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products: Guidance for Industry-Final Guidance

26 Nov 2019

Certificates of Confidentiality: Draft Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff-Draft Guidance

22 Nov 2019

CVM GFI #256 – Compounding Animal Drugs from Bulk Drug Substances-Draft Guidance

20 Nov 2019

Transdermal and Topical Delivery Systems – Product Development and Quality Considerations-Draft Guidance

20 Nov 2019

Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention Guidance for Industry-Final Guidance

15 Nov 2019

Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices: Guidance for Industry and Food and Drug Administration Staff-Final Guidance

14 Nov 2019

 

Upcoming Meetings (* = New)

*

January 14, 2020 Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement – 01/14/2020 – 01/14/2020

*

January 15, 2020 Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement – 01/15/2020 – 01/15/2020

*

January 16, 2020: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement – 01/16/2020 – 01/16/2020

Last updated: 06 January 2020

Dec 20 2019

What’s New Health Canada? November 2019 Updates

By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate

 

What’s New in:

 

Updates from Health Canada

Type of Update and Link Date Posted
Notice – Update to Clinical Trial Site Information Form 29 November 2019
Notice – Submitting Master File Transactions via the Common Electronic Submissions Gateway (CEGS) 29 November 2019

 

Santé Canada: Quoi de neuf?

Par Alejandra Gomez Perez. M.Sc., Associée, Affaires Réglamentaires

 

Quoi de neuf :

 

Mises à jour de Santé Canada

Genre de mise à jour et lien Date
Avis – Mise à jour du formulaire d’information sur le lieu de l’essai clinique 29 novembre 2019
Avis – Soumission de transactions de fiches maîtresses par l’entremise du Portail commun de demandes électroniques (PDCE) 29 novembre 2019

Dec 20 2019

New FDA guidance on alternate approaches in premarket notification for Class II medical devices

By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research

FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications”.

Instead of the traditional 510(k), manufacturers may choose an alternative approach: to submit an abbreviated 510(k) to demonstrate substantial equivalence in premarket notification for class II medical devices, relying on one or more of the following:

  • FDA guidance document(s)

The use of guidance documents may facilitate the review through a reliance on a summary report that summarize the device description, the manufacturer’s device design, risk management, and a description of test methods used to address performance characteristics as recommended in relevant guidance document(s). The report should include information regarding any deviations or alternative methods used to demonstrate substantial equivalence that are not described in the guidance.

  • Special controls

The use of special control may also facilitate the review through reliance on a summary report that describes how a special control has been used to address a special risk or issue. Special controls are defined in section 513(a)(1)(B) of the FD&C Act as those controls, such as performance standards, postmarketing surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions that provide reasonable assurance of device’s safety and effectiveness.

  • Voluntary consensus standards

Manufacturers submitting an abbreviated 510(k) that relies on general use of a voluntary consensus standard should include a summary report describing the basis of such use along with the underlying information or data that supports how the standard was used.

The guidances “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices” and “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in CBER” should be consulted.

Appendix A of the September 2019 guidance should be carefully referenced along with two other FDA guidances: “Refuse to Accept Policy for 510(K)s” and “Format for Traditional and Abbreviated 510(K)s”.

FDA believes that its review of abbreviated 510(k)s may be more efficient than that of traditional 510(k) submissions allowing for more efficient use of FDA’s review resources. However, FDA still intends to review abbreviated 510(k)s within the 90 days specified for 510(k) applications in the 2017 Medical Device User Fee Amendments, which is the same as the review period for a traditional 510(k).

Nov 06 2019

New FDA Guidances for October 2019 and Upcoming Adcom Meetings

By Sheila Plant, PhD, MHS, RAC (US), Director, Regulatory Strategy at Cato Research

Special Interest Guidances/Information Date Posted
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 – Draft Guidance 01 November 2019
Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry – Draft Guidance 01 November 2019
Electronic Submission of IND Safety Reports Technical Conformance Guide : Guidance for Industry – Final Guidance 30 October 2019
Providing Regulatory Submissions in Electronic Format: IND Safety Reports: Guidance for Industry – Draft Guidance 30 October 2019
Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry – Draft Guidance 28 October 2019
Breast Implants – Certain Labeling Recommendations to Improve Patient Communication: Draft Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 24 October 2019
Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry: Draft Revised Draft – Draft Guidance 24 October 2019
Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry – Draft Guidance 24 October 2019
Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers – Final Guidance 22 October 2019
Drug Master Files Guidance for Industry – Draft Guidance 18 October 2019
Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry – Final Guidance 16 October 2019
Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review: Guidance for Industry; Technical Specifications Document – Final Guidance 15 October 2019
Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 10 October 2019
Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 10 October 2019
Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry – Final Guidance 09 October 2019
Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus: Guidance for Industry – Final Guidance 02 October 2019
Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment: Guidance for Industry – Final Guidance 02 October 2019
Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry – Final Guidance 30 September 2019
   
Upcoming Meetings (* = New)
November 6-7, 2019: General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee Meeting
  November 8, 2019: Vaccines and Related Biological Products Advisory Committee Meeting
  November 13, 2019: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting
  November 13-14, 2019: Immunology Devices Panel of the Medical Devices Advisory Committee Meeting

*

November 14, 2019: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting

*

Blood Products Advisory Committee November 22, 2019 Meeting

   Last updated: 05 November 2019

Oct 18 2019

What’s New Health Canada? August and September 2019 Updates

What’s New Health Canada?

By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate

 

What’s New in:

 

Updates from Health Canada

 

Type of Update and Link Date Posted
Updated notice: Mandatory Use of the Electronic Common Technical Guidance (eCTD) Format 13 September 2019
The Regulatory Enrolment Process (REP) is now in production. All regulatory transactions for human drugs, pursuant to Division 1 and 8 of the Food and Drug Regulations are encouraged use REP with regulatory transactions prepared in both eCTD and non-eCTD formats. The REP information page has been updated to include the REP Guidance Document, REP templates as well as information on REP pilots coming up for Veterinary Drugs and Clinical Trials. 28 August 2019
Notice: Regulatory Enrolment Process (REP) Pilot for Clinical Trials 28 August 2019
Master File (MF) Application Fee Form for Human Drugs 14 August 2019
Release of the revised Guidance Document: Post-Notice of Compliance (NOC) Changes – Safety and Efficacy 12 August 2019
Revisions to the Guidance Document: Questions & Answers: Plain Language Labelling Regulations for Prescription Drugs 08 August 2019
Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines Update 06 August 2019

 

Santé Canada: Quoi de neuf?

Par Christine Straccini, B.Sc., C.C.R.P., Associée réglementaire

 

Quoi de neuf :

 

Mises à jour de Santé Canada

 

Genre de mise à jour et lien Date
Avis mise à jour : Utilisation obligatoire du format Electronic Common Technical Document (eCTD) 13 septembre 2019
Le processus d’inscription réglementaire (PIR) est maintenant en production. Conformément aux titres 1 et 8 du Règlement sur les aliments et drogues, toutes les transactions réglementaires concernant des drogues à usage humain sont encouragées à utiliser PIR avec les transactions réglementaires préparées dans les formats eCTD et non eCTD. La page d’informations REP a été mise à jour pour inclure le document d’orientation PIR, les modèles PIR ainsi que des informations sur les pilotes PIR à venir pour les médicaments vétérinaires et les essais cliniques. 28 août 2019
Avis : Projet pilote relatif au processus d’inscription réglementaire (PIR) pour les essais cliniques 28 août 2019
Formulaire sur les frais pour Fiche maîtresse pour les médicaments à usage humain 14 août 2019
Publication de la Ligne directrice : Changements survenus après l’avis de conformité (AC) : Document sur l’innocuité et l’efficacité 12 août 2019
Modifications apportées la ligne directrice : Question et réponses : Le règlement sur l’étiquetage en langage clair pour les médicaments délivrés sur ordonnance 08 août 2019
Avis : Consultation publique conjointe entre Santé Canada et de la Food and Drug Administration des États Unis sur les lignes directrices de l’International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Mise à jour 06 août 2019

Oct 08 2019

New FDA Guidances for September 2019

Special Interest Guidances/Information Date Posted
Patient-Focused Drug Development: Methods to Identify What Is Important to Patients – Draft Guidance 30 Sep 2019
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act – Final Guidance 27 Sep 2019
Clinical Decision Support Software – Draft Guidance 27 Sep 2019
General Wellness: Policy for Low Risk Devices – Final Guidance 27 Sep 2019
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices – Final Guidance 27 Sep 2019
Off-The-Shelf Software Use in Medical Devices – Final Guidance 27 Sep 2019
Policy for Device Software Functions and Mobile Medical Applications – Final Guidance 27 Sep 2019
Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act – Draft Guidance 26 Sep 2019
Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations – Draft Guidance 24 Sep 2019
Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment – Final Guidance 23 Sep 2019
The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program – Draft Guidance 23 Sep 2019
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy – Final Guidance 23 Sep 2019
Conventional Foley Catheters – Performance Criteria for Safety and Performance Based Pathway – Draft Guidance 20 Sep 2019
Cutaneous Electrodes for Recording Purposes – Performance Criteria for Safety and Performance Based Pathway – Draft Guidance 20 Sep 2019
Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products – Draft Guidance 20 Sep 2019
Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway – Draft Guidance 20 Sep 2019
Safety and Performance Based Pathway – Final Guidance 20 Sep 2019
Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway – Draft Guidance 20 Sep 2019
Safer Technologies Program for Medical Devices – Draft Guidance 19 Sep 2019
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act – Final Guidance 18 Sep 2019
Format for Traditional and Abbreviated 510(k)s – Final Guidance 13 Sep 2019
Refuse to Accept Policy for 510(k)s – Final Guidance 13 Sep 2019
The Abbreviated 510(k) Program – Final Guidance 13 Sep 2019
The Special 510(k) Program – Final Guidance 13 Sep 2019
Acceptance Review for De Novo Classification Requests – Final Guidance 09 Sep 2019
FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals – Final Guidance 09 Sep 2019
User Fees and Refunds for De Novo Classification Requests – Final Guidance 09 Sep 2019
Humanitarian Device Exemption (HDE) Program – Final Guidance 06 Sep 2019
Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older – Final Guidance 05 Sep 2019
Humanitarian Use Device (HUD) Designations – Final Guidance 05 Sep 2019
Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers – Final Guidance 04 Sep 2019
 
Upcoming Meetings (* = New)
  October 9, 2019: Vaccines and Related Biological Products Advisory Committee Meeting Announcement
  October 16, 2019: Antimicrobial Drugs Advisory Committee Meeting Announcement

*

October 29, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement
  October 30, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement
  November 6-7, 2019: General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
  November 8, 2019: Vaccines and Related Biological Products Advisory Committee Meeting Announcement

*

November 13-14, 2019: Immunology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

*

November 14, 2019: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

Last updated: 04 October 2019

Sep 09 2019

New FDA Guidances for June to August 2019

Special Interest Guidances/Information Date Posted
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions: Guidance for Industry and Food and Drug Administration Staff – Final 30 August 2019
Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications: Guidance for Industry and Food and Drug Administration Staff – Final 30 August 2019
Guidance for Industry: Policy Related to Cranberry Products with Added Flavorings – Final 30 August 2019
Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry – Final 28 August 2019
Male Breast Cancer: Developing Drugs for Treatment: Draft Guidance for Industry – Draft 27 August 2019
CVM GFI #257 (VICH GL57) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species – Final 19 August 2019
Guidance for Industry: Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels – Final 15 August 2019
Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment Guidance for Industry: Guidance for Industry – Final 14 August 2019
Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry – Final 13 August 2019
Gastroparesis: Clinical Evaluation of Drugs for Treatment Guidance for Industry – Draft 13 August 2019
Fabry Disease: Developing Drugs for Treatment Guidance for Industry – Draft 07 August 2019
FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements: Guidance for Industry – Final 02 August 2019
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Draft Guidance for Industry and Food and Drug Administration Staff – Draft 02 August 2019
“Harmful and Potentially Harmful Constituents” in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and FDA Staff – Final 02 August 2019
Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry – Final 01 August 2019
Bacterial Vaginosis: Developing Drugs for Treatment Guidance for Industry – Final 31 July 2019
E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES – Draft 31 July 2019
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry – Draft 31 July 2019
Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers – Draft 31 July 2019
Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment Guidance for Industry – Final 31 July 2019
Vulvovaginal Candidiasis: Developing Drugs for Treatment – Final 31 July 2019
Rare Pediatric Disease Priority Review Vouchers: Draft Guidance for Industry – Draft 30 July 2019
Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention Guidance for Industry – Final 26 July 2019
Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff – Final 26 July 2019
CVM GFI #181 Blue Bird Medicated Feed Labels – Final 23 July 2019
Providing Regulatory Submissions in Electronic Format–Submission of Manufacturing Establishment Information Guidance for Industry – Draft 23 July 2019
Postmarketing Safety Reporting for Combination Products: Guidance for Industry and FDA Staff – Final 22 July 2019
Submitting Next Generation Sequencing Data to the Division of Antiviral Products Guidance for Industry Technical Specifications Document – Final 18 July 2019
Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry: Draft Clinical/Medical – Draft 17 July 2019
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry – Draft 16 July 2019
Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy Guidance for Industry – Draft 11 July 2019
Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff – Final 11 July 2019
Population Pharmacokinetics – Draft 11 July 2019
Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry – Draft 10 July 2019
Using the Inactive Ingredient Database Guidance for Industry – Draft 10 July 2019
Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry – Final 09 July 2019
Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect Guidance for Industry – Final 05 July 2019
Center for Devices and Radiological Health (CDRH) Appeals Processes: Guidance for Industry and Food and Drug Administration Staff – Final 02 July 2019
Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A: Guidance for Industry and Food and Drug Administration Staff – Final 02 July 2019
Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry – Draft 01 July 2019
Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for Industry – Draft 01 July 2019
Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Guidance for Industry – Final 28 June 2019
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers : Guidance for Industry and Food and Drug Administration Staff – Final 27 June 2019
Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry – Draft 27 June 2019
Clinical Investigations for Prostate Tissue Ablation Devices: Draft Guidance for Industry and Food and Drug Administration Staff – Draft 26 June 2019
E19 OPTIMISATION OF SAFETY DATA COLLECTION – Draft 26 June 2019
M10 BIOANALYTICAL METHOD VALIDATION – Draft 26 June 2019
Draft Guidance for Industry: Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting – Draft 24 June 2019
Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs – Final 21 June 2019
Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry – Draft 20 June 2019
Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507 – Final 19 June 2019
Guidance for Industry: Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry Products – Final 18 June 2019
Mouse Embryo Assay for Assisted Reproduction Technology Devices – Draft 13 June 2019
Testing for Biotin Interference in In Vitro Diagnostic Devices: Draft Draft Guidance for Industry – Draft 13 June 2019
ANDA Submissions — Content and Format of Abbreviated New Drug Applications: Guidance for Industry – Final 12 June 2019
Applications for Premarket Review of New Tobacco Products – Draft 11 June 2019
Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS): Guidance for Industry – Final 11 June 2019
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry – Draft 06 June 2019
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry – Draft 06 June 2019
Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment Guidance for Industry – Draft 06 June 2019
Draft Guidance for Industry: Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption – Draft 03 June 2019
CPG Sec. 651.100 Ethylenediamine Dihydroiodide (EDDI) – Final 01 June 2019
Upcoming Meetings (* = New)
* Vaccines and Related Biological Products Advisory Committee November 8, 2019 Meeting Announcement – 11/08/2019 – 11/08/2019
* November 6-7, 2019: General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee Meeting Announcement – 11/06/2019 – 11/07/2019
* October 30, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement – 10/30/2019 – 10/30/2019
* October 16, 2019: Antimicrobial Drugs Advisory Committee Meeting Announcement – 10/16/2019 – 10/16/2019
* Vaccines and Related Biological Products Advisory Committee October 9, 2019 Meeting Announcement – 10/09/2019 – 10/09/2019
* September 27, 2019: Meeting of the Pediatric and Drug Safety and Risk Management Committees – 09/27/2019 – 09/27/2019
* September 26, 2019: Meeting of the Pediatric and Drug Safety and Risk Management Advisory Committees – 09/26/2019 – 09/26/2019
* September 18, 2019: Meeting of the Nonprescription Drugs Advisory Committee Meeting Announcement – 09/18/2019 – 09/18/2019
* Allergenic Products Advisory Committee September 13, 2019 Meeting Announcement – 09/13/2019 – 09/13/2019
* September 10, 2019: Patient Engagement Advisory Committee Meeting Announcement – 09/10/2019 – 09/10/2019

Last updated: 09 September 2019

Aug 26 2019

What’s New Health Canada? June and July 2019 Updates

 

What’s New Health Canada?

By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate

  

What’s New in:

Therapeutic Products Directorate:

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html

Biologics and Genetic Therapies Directorate:

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php

Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html

Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html

 

Updates from Health Canada

 

Type of Update and Link Date Posted
Release of the revised Post-Notice of Compliance (NOC) Changes – Quality Guidance 31 July 2019
Release of the revised Notice regarding the Post-Notice of Compliance (NOC) Changes- Notices of Change: Level III Form 31 July 2019
Revisions to the Guidance Document: Management of Drug Submissions and Applications 25 July 2019
Organisation and Document Placement for Canadian Module 1 of the Common Technical Document (CTD) Structure 17 July 2019
Notice: Revisions to the Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs 28 June 2019
Consultation on: Draft Guidance: Canadian Module 1 Technical Implementation Guide for the Electronic Common Technical Document (eCTD) v4.0 Format 26 June 2019
Notice – New regulatory activity types for filing to the Marketed Health Products Directorate (MHPD) 21 June 2019
Notice – Regulatory Enrolment Process (REP) implementation and expansion of the scope for the Common Electronic Submissions Gateway (CESG) 20 June 2019
Update Noticed: Introduction of the Regulatory Enrolment Process (REP) and the Use of the Common Electronic Submission Gateway (CESG) for Medical Devices 07 June 2019
Updated Product Monograph Template – Schedule D and Schedule D Biosimilar Biologic Drug 04 June 2019

 

Santé Canada: Quoi de neuf?

Par Christine Straccini, B.Sc., C.C.R.P., Associée réglementaire

 

Quoi de neuf :

Direction des produits thérapeutiques

https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/quoi-neuf-medicaments-sante-canada.html

Direction des produits biologiques et thérapies génétiques:

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-fra.php

Instruments médicaux: https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/instruments-medicaux/quoi-neuf.html

Direction des produits de santé naturels et sans ordonnance:

https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/naturels-sans-ordonnance/quoi-de-neuf.html

 

Mises à jour de Santé Canada

 

Genre de mise à jour et lien Date
Publication de la version révisée de la Ligne directrice: Changements survenus après l’avis de conformité (AC) : Document sur la qualité  

31 juillet 2019

Révision du Formulaire de déclaration de changements de niveau III de Santé Canada : Changements survenus après l’avis de conformité (AC)  

31 juillet 2019

Révisions à la ligne directrice : Gestion des présentations et des demandes de drogues  

25 juillet 2019

Organisation et emplacement des documents pour le module 1 canadien de la structure Common Technical Document (CTD)  

17 juillet 2019

Avis : Révisions du Ligne Directrice: Traitement administratif des présentations et des demandes concernant les médicaments destinés aux humains ou les désinfectants  

28 juin 2019

Consultation portant sur : L’ébauche de la ligne directrice: Guide de mise en œuvre technique du module 1 canadien pour le format Electronic Common Technical Document (eCTD) v. 4.0  

26 juin 2019

Avis – Nouveaux types d’activité de réglementation à présenter à la Direction des produits de santé commercialisés (DPSC)  

21 juin 2019

Avis – Mise en œuvre du Processus d’inscription réglementaire (PIR) et expansion du portail commun de demandes électroniques (PCDE)  

20 juin 2019

Mise à jour Avis : Implantation du processus d’inscription réglementaire (PIR) et de l’utilisation du portail commun de demandes électroniques (PCDE) pour les instruments médicaux  

07 juin 2019

Mise à jour le Modèle de monographie de produit – Annexe D et Annexe D médicament biologique biosimilaire  

04 juin 2019

 

 

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