Jan 17

Stay on the Safe Side- Reference Safety Information – Europe

Vivienne Ben-David, B.Sc. (Pharmacy) PGDip.

Project Manager & Associate Director, Pharmacovigilance ROW Cato Research

 

Aside from New Year’s resolutions and a clean sweep, what else should you refresh in 2019?

I politely suggest your understanding of Reference Safety Information (RSI) in the EU.

In Nov 2017, the Clinical Trials Facilitation Group published the Reference Safety Information Q&A document, and followed in March 2018 with a cover note. The latter explains that the recommendations in the Q&A document will be implemented more strictly from the beginning of January 2019.

The RSI future is now. Or is it old news? Well, it’s a bit of both, seemingly.

In 2011, the EU guidance (CT-3) on adverse events and reactions clearly stated that the expectedness of an adverse reaction is determined by the sponsor in the reference safety information (‘RSI’).

More recently, Competent Authorities across Europe have since provided sponsors with detail on what Reference Safety Information is and isn’t. For example, the Investigator’s Brochure is not the RSI; there should be a distinct section in the IB entitled ‘Reference Safety Information’.

The RSI should list serious adverse reactions (SARs) which are considered expected with the investigational product. It should not include SARs observed with any similar products in the same drug group. And note: SARs that have occurred once are generally consider unexpected. You have to provide a robust justification for including those one-timers in the RSI.

Seriously?  Absolutely, include only SARs in your RSI; non-serious reactions can be included in a different section.

It’s not hard to understand, but ignore it and you might feel the only heat in wintery Europe.

If you want your clinical trial application to go smoothly or approval of your next IB update – brush up on the details by reading the Q&A, clarify your understanding with your pharmacovigilance colleagues and keep your clinical trial subjects, and your product, on the safe side.

 

Jan 04

New FDA Guidances for December 2018

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist II at Cato Research

FDA draft and final guidances released from CDER, CBER, and CDRH in December are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

 

Special Interest Guidances/Information Date Posted
Labeling of Red Blood Cell Units with Historical Antigen Typing Results – Final Guidance 20 Dec 2018
Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data – Draft Guidance 20 Dec 2018
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics – Final Guidance 19 Dec 2018
Breakthrough Devices Program – Final Guidance 18 Dec 2018
Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment – Draft Guidance 17 Dec 2018
User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications – Final Guidance 12 Dec 2018
Data Integrity and Compliance With Current Good Manufacturing Practice – Final Guidance 12 Dec 2018
Biomarker Qualification: Evidentiary Framework – Draft Guidance 11 Dec 2018
Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 – Draft Guidance 11 Dec 2018
The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers – Draft Guidance 11 Dec 2018
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2) – Draft Guidance 11 Dec 2018
Questions and Answers on Biosimilar Development and the BPCI Act – Final Guidance 11 Dec 2018
Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act – Draft Guidance 10 Dec 2018
Bacterial Risk Control Strategies for Blood Collections Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion – Draft Guidance 04 Dec 2018
Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA – Final Guidance 03 Dec 2018
Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment – Final Guidance 03 Dec 2018
Upcoming Meetings (* = New)  
  January 11, 2019: Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
  January 16, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement
  January 17, 2019: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
* February 6-7, 2019: Tobacco Products Scientific Advisory Committee Meeting Announcement
* February 12, 2019: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
Last updated: 31 December 2018

Dec 27

What’s New Health Canada?

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy

 

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 (Drugs and Biologics)

 

Type of Update and Link Date Posted
Notice: Validation rules for regulatory transactions provided to Health Canada in the “non-eCTD electronic-only” format 30 November 2018
Notice – Validation rules for regulatory transactions submitted to Health Canada in the electronic Common Technical Document (eCTD) format 30 November 2018
Updated: Notice – Revision to the Post-Notice of Compliance (NOC) Changes – Notices of Change: Level III Form 30 November 2018
Health Canada Notice regarding products that contain human placenta 29 November 2018

 

 

 

Santé Canada: Quoi de neuf?

Par Amélie Rodrigue-Way, Ph.D., RAC (CAN), Directrice associée, Stratégie 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 (Médicaments et Produits biologiques)

 

Genre de mise à jour et lien Date
Avis : Règles de validation des transactions réglementaires envoyées à Santé Canada en format « électronique autre que le format eCTD » 30 novembre 2018
Avis – Règles de validation des transactions réglementaires soumises par Santé Canada en format electronic Common Technical Document (eCTD) 30 novembre 2018
Avis – Révision du Formulaire de déclaration de changements de niveau III de Santé Canada : Changements survenus après l’avis de conformité (AC) 30 novembre 2018
Avis de Santé Canada concernant les produits contenant du placenta humain 29 novembre 2018

 

Dec 11

New FDA Guidances for November 2018

By Joanne McNelis, Ph.D., RAC (US), Clinical Strategy Scientist II at Cato Research

FDA draft and final guidances released from CDER, CBER, and CDRH in October are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

 

Special Interest Guidances/Information Date Posted
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use – Draft Guidance 30 Nov 2018
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use – Draft Guidance 30 Nov 2018
Recommendations for Dual 510(k) and CLIA Waiver by Application Studies – Draft Guidance 29 Nov 2018
Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials – Draft Guidance 13 Nov 2018
Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products Guidance for Industry – Draft Guidance 06 Nov 2018
Hypertension: Developing Fixed-Dose Combination Drugs for Treatment Guidance for Industry – Final Guidance 06 Nov 2018
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking – Immediately in Effect Guidance for Industry and Food and Drug Administration Staff – Final Guidance 05 Nov 2018
Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment – Draft Guidance 01 Nov 2018
Upcoming Meetings (* = New)
December 17-18, 2018: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
* January 11, 2019: Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
* January 16, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement
* January 17, 2019: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
Last updated: 07 November 2018

Dec 04

Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

By Denis Okumu, Ph.D., Postdoctoral Fellow at Cato Research Ltd

Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

Section 801 of the Food and Drug Administration Amendment Act of 2007 (FDAAA) amended section 402(j) of the Public Health Service (PHS) Act[1] to require that responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, and device products (hereafter, “submitters”) submit registration and/or results information to the ClinicalTrials.gov data bank and/or certain certifications to FDA for certain “applicable clinical trials.”  Form FDA 3674[2] offers guidance on certifications to accompany such applications/submissions.  42 CFR Part 11 stipulates that a clinical trial must be registered within 21 calendar days of enrollment of the first subject, and results must be submitted no later than 1 year after the primary completion date of the applicable clinical trial.  Section 303(f)(3)[3] of the Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess civil money penalties against submitters who violate applicable prohibitions found in section 301(j) of the FD&C Act relating to requirements cited above under section 402(j).  Accordingly, FDA’s Draft Guidance  (September 2018) describes the current thinking of FDA’s Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH) (hereafter, “Center” or collectively, “the Centers”), regarding civil money penalties against submitters who fail to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank, submit false or misleading information to the data bank, fail to submit to FDA the certification required, or knowingly submit a false certification.  The draft document comes against a backdrop of recent findings that show increasing numbers of clinical trials on the European Register, as well as US industry trials and NIH-sponsored research did not report results as required.[4],[5]

The Centers intend to identify violations relating to posting on ClinicalTrials.gov data bank through evidence collected during inspections conducted as part of FDA’s Bioresearch Monitoring Program (BIMO) as well as from complaints the agency may receive.  FDA’s Bioresearch Monitoring Compliance Program Guidance Manual 7348.810 for Sponsors, Contract Research Organizations and Monitors[6] outlines how the Centers will gather information to assess compliance with the above requirements:

  • determine whether the study is an applicable clinical trial
  • determine the submitter, the address, and contact information for the submitter
  • determine whether the study was registered on ClinicalTrials.gov and identify the National Clinical Trial Number
  • determine whether the study was registered not later than 21 days of enrollment of the first subject
  • determine the study’s completion date
  • determine whether the submitter has completed and submitted Form FDA 3674
  • determine whether, on the informed consent form, it states that a description of the clinical trial will be available on ClinicalTrials.gov

When a Center believes an infraction has occurred, it will send the submitter a Preliminary Notice of Noncompliance (Pre-Notice) Letter that describes the potential violation and asks the submitter to review the online data bank and make any necessary revisions within 30 days of receiving the letter.  The Center makes it clear in this letter that a further review and assessment of the online data bank will be done after 30 days, and that failure to comply with the requirements may result in the issuance of a Notice of Noncompliance under section 402(j)(5)(C)(ii) of the PHS Act.[7]  The Notice of Noncompliance gives the submitter an additional 30 days to remedy noncompliance.  If noncompliance is not remedied after 30 days, the Center will seek civil money penalties, injunction, and/or criminal prosecution.

Civil money penalty actions start when the responsible Center files a Complaint with FDA’s Division of Dockets Management and serves the Complaint on the submitter.  The Complaint will detail allegations of liability, violations, reasons why the submitter is responsible for the violations, and the amount of money penalties and assessments sought.  The Complaint also includes instructions to the submitter on how to file an Answer to request a hearing within 30 days of service, and warns that failure to do this will lead to imposition of the sought amount of penalties and assessments as provided in law.  Upon being served, the submitter may pay the penalty sought in the Complaint, or file an Answer to contest some or all of the Center’s allegations.  While waiting for a hearing, a submitter and its representatives may engage in settlement discussions with the Center regarding the civil money penalty.  If the case is decided by a presiding officer, any dissatisfied party can appeal to the Department of Health and Human Services (HHS) Departmental Appeals Board (DAB), pursuant to 21 CFR 17.47.  As outlined in section 303(f)(6) of the FD&C Act,[8] the respondent may appeal an adverse DAB decision to the U.S. Court of Appeals for the District of Columbia or any other circuit in which the respondent resides or transacts business.

If a violation is not corrected within 30 days following notification of such violation, section 303(f)(3)(A) of the FD&C Act[9] stipulates statutory maximum penalties of not more than $10,000 for all violations adjudicated in a single proceeding, and not more than $10,000 for each day that the violation continues uncorrected as described in section 303(f)(3)(B) of the FD&C Act.[10]  Per section 303(f)(5)(B) of the FD&C Act,[11] the amount of civil money penalty under the relevant statutory limits is dependent on the nature, circumstances, extent and gravity of the violation(s), and the violator’s ability to pay, effect on ability to stay in business, any history of prior such violations, the degree of culpability and any other considerations as justice may require.

 

[1] 42 U.S.C. 282(j)

[2] Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions

[3] 21 U.S.C. 333(f)(3)

[4] Goldacre et al., 2018. Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource

[5] Anderson et al., 2015. Compliance with Results Reporting at ClinicalTrials.gov

[6] FDA Compliance Program Guidance Manual 7348.810 Sponsors, Contract Research Organizations and Monitors

[7] 42 U.S.C. 282(j)(5)(C)(ii)

[8] 21 U.S.C. 333(f)(6)

[9] 21 U.S.C. 333(f)(3)(A)

[10] 21 U.S.C. 333(f)(3)(B)

[11] 21 U.S.C. 333(f)(5)(B)

Nov 06

New FDA Guidances for October 2018

By Joanne McNelis, Ph.D., RAC (US), Clinical Strategy Scientist II at Cato Research

FDA draft and final guidances released from CDER, CBER, and CDRH in October are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

 

Special Interest Guidances/Information Date Posted
Considerations for the Development of Dried Plasma Products Intended for Transfusion – Draft Guidance 30 Oct 2018
M9 Biopharmaceutics Classification System-Based Biowaivers – Draft Guidance 25 Oct 2018
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance for Industry – Draft Guidance 25 Oct 2018
Testicular Toxicity: Evaluation During Drug Development Guidance for Industry – Final Guidance 24 Oct 2018
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices – Draft Guidance 18 Oct 2018
Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements Guidance for Industry – Draft Guidance 16 Oct 2018
Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment Guidance for Industry – Draft Guidance 15 Oct 2018
Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry – Draft Guidance 15 Oct 2018
Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease; Guidance for Industry – Final Guidance 15 Oct 2018
Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Draft Guidance for Industry – Revised Draft Guidance 09 Oct 2018
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry – Draft Guidance 09 Oct 2018
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act – Draft Guidance (revised final) 02 Oct 2018
Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use – Final Guidance 02 Oct 2018
Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs – Final Guidance 02 Oct 2018
Upcoming Meetings (* = New)  
* November 8, 2018: Vaccines and Related Biological Products Advisory Committee Meeting Announcement
* November 14, 2018: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
  November 15, 2018: Patient Engagement Advisory Committee Meeting Announcement
* November 15, 2018: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement
* December 4-5, 2018: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
* December 4-5, 2018: Science Advisory Board to NCTR Meeting Announcement
* December 17-18, 2018: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
Last updated: 05 November 2018

 

Oct 02

New FDA Guidances for September 2018

By Zachary Swan, Ph.D., Regulatory Scientist at Cato Research

FDA draft and final guidances released from CDER, CBER, and CDRH in September are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

 

Special Interest Guidances/Information Date Posted
Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act – Final Guidance

The Special 510(k) Program – Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance

Adaptive Design Clinical Trials for Drugs and Biologics – Draft Guidance

Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry – Draft Guidance

Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications Guidance for Industry and FDA Staff – Draft Guidance

28 Sep 2018
Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls – Draft Guidance 26 Sep 2018
Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities Guidance for Industry – Final Guidance

Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry – Final Guidance

Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics – Final Guidance

Guidance for Industry and Food and Drug Administration Staff – Final Guidance

Insanitary Conditions at Compounding Facilities Guidance for Industry – Draft Guidance

25 Sep 2018
Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications – Draft Guidance

ANDA Submissions — Content and Format of Abbreviated New Drug Applications – Final Guidance

24 Sep 2018
Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing – Guidance for Industry and Food and Drug Administration Staff – Final Guidance

Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank – Draft Guidance

20 Sep 2018
Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers – Final Guidance

Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry – Final Guidance

Product Identifiers under the Drug Supply Chain Security Act – Questions and Answers – Draft Guidance

Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier – Final Guidance

19 Sep 2018
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices – Guidance for Industry and Food and Drug Administration Staff – Final Guidance

Recognition and Withdrawal of Voluntary Consensus Standards – Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance

510(k) Third Party Review Program – Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations – Draft Guidance

14 Sep 2018
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions – Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 06 Sep 2018
Nonallergic Rhinitis: Developing Drug Products for Treatment – Final Guidance

Allergic Rhinitis: Developing Drug Products for Treatment Guidance for Industry – Final Guidance

05 Sep 2018
Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry – Final Guidance 04 Sep 2018
Draft Guidance for Industry: Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials – Draft Guidance 01 Sep 2018
Upcoming Meetings (* = New)
October 3, 2018: Vaccines and Related Biological Products Advisory Committee
* October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee
* October 11, 2018: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement
* October 12, 2018: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement
* October 17, 2018: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
* October 18, 2018: Meeting of the Gastrointestinal Drugs Advisory Committee Meeting Announcement
* October 22, 2018: Science Board to the FDA Meeting Announcement
* October 24-25, 2018: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
* November 1, 2018: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee & Drug Safety and Risk Management Advisory Committee Meeting Announcement
* November 2, 2018: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee & Drug Safety and Risk Management Advisory Committee Meeting Announcement
* November 7, 2018: Allergenic Products Advisory Committee Meeting Announcement
* November 15, 2018: Patient Engagement Advisory Committee Meeting Announcement
Last updated: 01 October 2018

Sep 06

New FDA Guidances for August 2018

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist II at Cato Research

 

FDA draft and final guidances released from CDER, CBER, and CDRH in August are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

 

Special Interest Guidances/Information Date Posted
Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development– Draft Guidance 23 Aug 2018
Osteoarthritis: Structural Endpoints for the Development of Drugs – Draft Guidance 22 Aug 2018
Quality Attribute Considerations for Chewable Tablets – Final Guidance 20 Aug 2018
Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations – Final Guidance 20 Aug 2018
Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices – Draft Guidance 17 Aug 2018
Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics – Draft Guidance 10 Aug 2018
Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances – Final Guidance 08 Aug 2018
Elemental Impurities in Drug Products – Final Guidance 07 Aug 2018
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment – Draft Guidance 06 Aug 2018
Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products – Draft Guidance 03 Aug 2018
Medical Device User Fee Small Business Qualification and Certification – Final Guidance 01 Aug 2018
Upcoming Meetings (* = New)
* September 12, 2018: Meeting of the Pharmacy Compounding Advisory Committee
September 20, 2018: Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee
* September 20, 2018: Pediatric Advisory Committee Meeting
* September 27, 2018: Neurological Devices Panel of the Medical Devices Advisory Committee
* October 3, 2018: Vaccines and Related Biological Products Advisory Committee
Last updated: 05 September 2018

 

Aug 16

New FDA Guidances for June and July 2018

By Joanne McNelis, PhD, RAC (US), Scientist at Cato Research

FDA draft and final guidances, released from CDER, CBER, and CDRH, in April are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

 

Special Interest Guidances/Information Date Posted
Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Draft Guidance for Industry – Draft Guidance 27 July 2018
Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions – Draft Guidance 27 July 2018
Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies Guidance for Industry – Draft Guidance 26 July 2018
Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments – Draft Guidance 24 July 2018
Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development: Guidance for Industry – Draft Guidance 23 July 2018
E17 General Principles for Planning and Design of Multi-Regional Clinical Trials – Final Guidance 18 July 2018
Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry – Final Guidance 18 July 2018
Labeling for Biosimilar Products Guidance for Industry – Final Guidance 18 July 2018
Field Alert Report Submission: Questions and Answers Guidance for Industry – Draft Guidance 18 July 2018
Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions – Draft Guidance 18 July 2018
Innovative Approaches for Nonprescription Drug Products – Draft Guidance 17 July 2018
Q3D(R1) ELEMENTAL IMPURITIES – Draft Guidance 13 July 2018
Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry – Draft Guidance 11 July 2018
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Draft Guidance for Industry – Draft Guidance 11 July 2018
Long Term Follow-up After Administration of Human Gene Therapy Products; Draft Guidance for Industry – Draft Guidance 11 July 2018
Human Gene Therapy for Hemophilia; Draft Guidance for Industry – Draft Guidance 11 July 2018
Human Gene Therapy for Rare Diseases; Draft Guidance for Industry – Draft Guidance 11 July 2018
Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry – Draft Guidance 11 July 2018
Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention – Draft Guidance 10 July 2018
Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry – Final Guidance 09 July 2018
Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry – Draft Guidance 06 July 2018
ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA – Final Guidance 03 July 2018
Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry – Draft Guidance 28 Jun 2018
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry – Final Guidance 28 Jun 2018
Major Depressive Disorder: Developing Drugs for Treatment – Draft Guidance 20 Jun 2018
Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry – Draft Guidance 20 Jun 2018
Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests – Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 15 Jun 2018
Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling – Draft Guidance 15 Jun 2018
Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations – Draft Guidance 15 Jun 2018
Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Draft Guidance for Industry – Draft Guidance 15 Jun 2018
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals–Questions and Answers – Final Guidance 15 Jun 2018
Humanitarian Device Exemption (HDE) Program – Draft Guidance 15 Jun 2018
Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis – Draft Guidance 13 Jun 2018
Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry – Draft Guidance 12 Jun 2018
Patient-Focused Drug Development: Collecting Comprehensive and Representative Input – Draft Guidance 12 Jun 2018
Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers Guidance for Industry – Final Guidance 12 Jun 2018
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers Guidance for Industry and Review Staff – Final Guidance 12 Jun 2018
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program – Draft Guidance 07 Jun 2018
Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief – Draft Guidance 06 Jun 2018
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry – Draft Guidance 04 Jun 2018
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials – Draft Guidance 01 Jun 2018
Complicated Urinary Tract Infections: Developing Drugs for Treatment – Final Guidance 01 Jun 2018
Upcoming Meetings (* = New)  
* September 20, 2018: Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Announcement
Last updated: 15 August 2018

Aug 15

What’s New Health Canada?

 

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy

 

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

 

 

Health Canada New Guidance Documents (Drugs and Biologics)

 

Health Canada Guidance Type Date Posted
Notifying Health Canada of Foreign Actions – Guidance Document for Industry – Summary Guidance 12 July 2018

 

Updates from Health Canada (Drugs and Biologics)

 

Type of Update and Link Date Posted
Therapeutic Products Directorate Statistical Report 2017/2018 11 July 2018
Notice: Australia Canada Singapore Switzerland (ACSS) Consortium – Approval of Erleada 13 July 2018

 

 

 

Santé Canada: Quoi de neuf?

 

Par Amélie Rodrigue-Way, Ph.D., RAC (CAN), Directrice associée, Stratégie 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

 

Nouvelles lignes directrices de Santé Canada (Médicaments et Produits biologiques)

 

Ligne directrice de Santé Canada Genre Date
Aviser Santé Canada des mesures prises dans les pays étrangers – Document d’orientation à l’intention de l’industrie – Sommaire ligne directrice 12 juillet 2018

 

Mises à jour de Santé Canada (Médicaments et Produits biologiques)

 

Genre de mise à jour et lien Date
Rapport statistique 2017/2018 de la Direction des produits thérapeutiques 11 juillet 2018
Avis : Consortium Australie-Canada-Singapour-Suisse (ACSS)- L’approbation d’Erleada 13 juillet 2018

blue arrow

Questions? Our Experts can help.
Contact Our Team Today!
Call: 919-361-2286 or Click Here to Send Us an E-mail

Older posts «