Apr 13

New FDA Guidances for February and March 2018

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

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

 

Special Interest Guidances/Information Date Posted
Chronic Obstructive Pulmonary Disease: Use of the St. George’s Respiratory Questionnaire as a PRO Assessment Tool Guidance for Industry – Final Guidance 26 Mar 2018
Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry – Draft Guidance 23 Mar 2018
Postmarketing Safety Reporting for Combination Products – Draft Guidance 21 Mar 2018
M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk – Final Guidance 13 Mar 2018
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry – Draft Guidance 02 Mar 2018
E18 Genomic Sampling and Management of Genomic Data Guidance for Industry – Final Guidance 01 Mar 2018
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry – Draft Guidance 28 Feb 2018
Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry – Draft Guidance 28 Feb 2018
E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) – Final Guidance 28 Feb 2018
Q11 Development and Manufacture of Drug Substances–Questions and Answers (Chemical Entities and Biotechnological/Biological Entities) – Final Guidance 23 Feb 2018
Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions; Guidance for Industry and Food and Drug Administration Staff – Final Guidance 21 Feb 2018
Migraine: Developing Drugs for Acute Treatment – Final Guidance 15 Feb 2018
Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment Guidance for Industry – Final Guidance 15 Feb 2018
Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment – Draft Guidance 15 Feb 2018
Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industy – Draft Guidance 15 Feb 2018
Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older – Draft Guidance 15 Feb 2018
Regulatory Classification of Pharmaceutical Co-Crystals – Revised Final Guidance 14 Feb 2018
Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry – Final Guidance 12 Feb 2018
Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation – Final Guidance 07 Feb 2018
Upcoming Meetings (* = New)
* May 2, 2018: Antimicrobial Drugs Advisory Committee Meeting Announcement
* May 3, 2018: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee Meeting Announcement
* May 10, 2018: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
* May 22, 2018: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
* April 19, 2018: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement
* April 23, 2018: Arthritis Advisory Committee Meeting
* April 24-25, 2018: Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
Last updated: 05 April 2018

Mar 27

Submitting IND Safety Reports using us-regional DTD v3.3 versus v2.01: What’s the Difference?

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

 

Submitting IND safety reports to an IND in eCTD format is slightly different when using us-regional DTD v3.3 versus v2.01.

Keep in mind that the following aspects remain UNCHANGED for both versions:

  • Each individual IND safety report should be provided in Section 5.3 of the eCTD under its associated study.
  • Each safety report should be referenced in the study’s STF using the ‘IND safety report’ file tag.
  • The eCTD leaf title should include “Safety Report” along with “initial” or “follow-up”, depending on the content of the individual safety report.
  • Leaf titles that clearly relate to the individual cases should be used.
  • Each IND safety report should be submitted as “new” without replacing any previously submitted information.
  • Multiple IND Safety Reports can be submitted in one sequence.

The DIFFERENCES are as follows:

  • When using v2.01:
  • IND Safety Report submissions are grouped by submission-type.
  • Submitted as “amendments” (submission-type) under the IND.
  • Related sequence number will be the sequence number of the IND’s original application (submission-type).

 

  • When using v3.3:
  • IND Safety Report submissions are grouped by submission-type and submission-subtype.
  • Submitted as “IND Safety Reports” (submission-type) and then either as “report” or “amendment” (submission-subtype).
  • First IND safety report submission using v3.3 should use a submission-type of “IND Safety Report” and submission-subtype of “report” in order to start the regulatory activity.
  • All subsequent IND Safety Report submissions can then be submitted as an “amendment” (submission-subtype) to the first “IND Safety Report” (submission-type) in the application.
  • The submission-ID for all IND Safety Report submissions will be the sequence number of the first submission to the “IND Safety Report” regulatory activity with submission-subtype of report”.

 

Questions about using v3.3:

Question:

Can “report” and “amendment” submission-subtypes be used for initial and follow-up IND Safety Reports, respectively?

Answer:

This is possible but then you will need to start a new regulatory activity for each IND Safety Report.  You will not be able to submit multiple IND Safety Reports in one sequence unless they are all either initial or follow-up reports since only one submission-subtype (report or amendment) can be used per sequence.  The same applies for the submission-ID.  You can only include one sequence for the submission-ID so even if you are submitting the same type of report in one sequence they will all need to have the same submission-ID, which may not be the case for follow-up reports.

This can get very cumbersome which is why I contacted the CDER ESUB group to get clarification.  It was explained to me that when using v3.3 or when transitioning to v3.3, it is acceptable to use “report” as the submission-subtype for the first IND Safety Report submission, regardless of whether the report(s) is(are) initial or follow-up. All subsequent initial or follow-up safety report submissions will then be submitted as an “amendment” under the same IND Safety Report regular activity.

Mar 08

Deadline to Begin Submitting Commercial INDs in eCTD Format is May 5, 2018

By Joshua Taylor, Ph.D., R.A.C. (US), Regulatory Scientist

Beginning on May 5, 2018, all commercial Investigational New Drug Applications (INDs) and master files must be submitted in the electronic common technical document (eCTD) format.

Section 745A(a) of the Food, Drug, and Cosmetic Act (FD&C Act) authorizes the United States Food and Drug Administration (FDA) to require that, no sooner than 24 months after issuance of a final guidance document in which the FDA has specified the electronic format for submitting submission types to FDA, such content must be submitted electronically and in the format specified by FDA. On May 5, 2015, FDA published a guidance titled Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Revision 4 published in April 2017) that established timelines of 24 months for electronic submissions of New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), certain Biologics License Applications (BLAs), and master files (May 5, 2017); and of 36 months for electronic submissions of commercial INDs (May, 5 2018).  After internal review and receiving comments from industry, FDA later determined that master files would instead follow the 36-month timeline as well (May 5, 2018).

The first deadline, applicable to marketing applications to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), arrived last year. Only marketing applications for drugs or combination products submitted under Section 505(b), (i), or (j) of the FD&C Act and marketing applications for biologics and combination products submitted under Section 351(a) or 351(k) of the Public Health Service Act were impacted.

However, the upcoming deadline of May 5, 2018, applicable to commercial INDs and master files, will affect companies at all stages of drug development. It is important to note, however, that the electronic submission requirements do not apply to submissions for blood and blood components and submissions for devices regulated by CBER, but electronic submissions of these types are still accepted.

 

blue arrowQuestions or concerns regarding this new regulation? Our Regulatory Experts can help.
Contact Our Regulatory Team Today!
Call: 919-361-2286 or Click Here to Send Us an E-mail

 

Common Questions
Common questions regarding electronic submission requirements and corresponding text from Revision 4 of Electronic Submission Requirements Guidance are presented below.

What types of submissions are exempt from electronic submission requirements?

“FDA has exempted all submissions regarding noncommercial INDs from the requirements under section 745A(a). For purposes of this guidance, the term noncommercial products refers to products that are not intended to be distributed commercially and includes investigator-sponsored INDs and expanded access INDs (e.g., emergency use INDs and treatment INDs).”

What format should be used for future submissions if the original application was submitted prior to the electronic requirement deadline?

“[Y]ou must electronically submit any amendments, supplements, and reports, even if the original submission was submitted to FDA prior to implementation of the electronic submission requirements.”

Why is FDA mandating that master files be submitted in electronic format, and what types of master files are affected?

“FDA considers master files to be submissions to an NDA, ANDA, BLA, or IND, and therefore to fall within the scope of requirements set forth in section 745A(a). These include new drug master files (DMFs) (21 CFR 314.420), new biological product files (BPFs) (21 CFR 601.51), and any amendments to or annual reports on previously submitted DMFs or BPFs.”

What is the penalty for noncompliance with electronic submission requirements?

“Submissions that are not submitted electronically and electronic submissions that are not in a format that FDA can process, review, and archive will not be filed or received, unless exempted from the electronic submission requirements.”

Mar 01

Submitting a “Request for Proprietary Name Review” in eCTD format to the FDA

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

Per the April 2016 Guidance for Industry entitled, “Contents of a Complete Submission for the Evaluation of Proprietary Names”, applicants must submit proposed proprietary names to the FDA for review as part of New Drug Applications (NDAs), Abbreviated NDAs (ANDAs) and Biologics License Applications (BLAs).  If such an application is not yet available, it is acceptable to submit the request to an active Investigational New Drug (IND) application provided the product has completed Phase 2 trials.

If submitting electronically in eCTD format, the request is placed in the following sections depending on the US regional DTD version being used:

  • US regional DTD v3.3
    • A “Request for Proprietary Name Review” is placed in “Section 1.18 Proprietary Names”
  • US regional DTD v2.01
    • A “Request for Proprietary Name Review” is placed in “Section 1.12.4 Request for Comments and Advice on an IND”

In both cases, the eCTD leaf title of the document should be clear, concise, and indicative of the document’s content (e.g. “REQUEST FOR PROPRIETARY NAME REVIEW”, “AMENDMENT TO REQUEST FOR PROPRIETARY NAME REVIEW”, or “REQUEST FOR RECONSIDERATION OF PROPRIETARY NAME”).  Moreover, the eCTD location of the request should be included and hyperlinked in the cover letter so the information can be quickly and easily accessed by reviewers.

The FDA will evaluate both safety and promotional aspects of the product’s proposed proprietary name; a tentative acceptance or non-acceptance about the name will be communicated to the applicant within 180 days during the IND phase and 90 days with an NDA or BLA.

Feb 20

New FDA Guidances for January 2018

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

 

FDA draft and final guidances released from CDER, CBER, and CDRH in January 2018 are posted.  CDRH has also released an “A-list” and a “B-list” of proposed guidances for fiscal year 2018 and is seeking feedback on the relative priority of guidance documents.  CDRH is also intending to conduct a focused retrospective review of guidances released in 2008, 1998, 1988, and 1978.  More information can be found here:   https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm580172.htm

In addition, upcoming advisory committee meetings are listed below with links to more information.

 

Special Interest Guidances/Information Date Posted
Qualified Infectious Disease Product Designation Questions and Answers 29 Jan 2018
Hypertension: Developing Fixed-Dose Combination Drugs for Treatment Guidance for Industry – Draft Guidance 25 Jan 2018
Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) – Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 19 Jan 2018
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application – Final Guidance 18 Jan 2018
Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry – Final Guidance 18 Jan 2018
Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry – Final Guidance 18 Jan 2018
Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry – Draft Guidance 18 Jan 2018
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff  – Final Guidance 16 Jan 2018
Good ANDA Submission Practices Guidance for Industry – Draft Guidance 03 Jan 2018
Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders Guidance for Industry – Draft Guidance 02 Jan 2018
Upcoming Meetings (* = New)
March 1, 2018: Neurological Devices Panel of the Medical Devices Advisory Committee
* March 8, 2018: Meeting of the Gastrointestinal Drugs Advisory Committee Meeting Announcement
* March 22, 2018: Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
* March 23, 2018: Pediatric Advisory Committee Meeting Announcement
Last updated: 15 February 2018

Feb 15

What’s New Health Canada?

By Sandra Salem, Ph.D., Regulatory Scientist

 

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, Biologics, Medical Devices and Natural & Non-prescription Health Products)

 

Health Canada Guidance Type Date Posted
Publication of the Final Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs Guidance 11 December 2017
Guidance Document: Classification of Products at the (Medical) Device-Drug Interface Guidance 08 February 2018

 

Updates from Health Canada (Drugs, Biologics, Medical Devices and Natural & Non-prescription Health Products)

 

Type of Update and Link Date Posted
Updated: Notice – Mandatory use of the Electronic Common Technical Document (eCTD) format 12 January 2018
Notice: Adoption of International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance Document: M7 19 January 2018

 

  

 

Santé Canada: Quoi de neuf?

 

Par Sandra Salem, Ph.D., Scientifique 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, Produits biologiques, Instruments médicaux et Produits de santé naturels et sans ordonnance)

 

Ligne directrice de Santé Canada Genre Date
Publication de la version définitive de la Ligne directrice : Traitement administratif des présentations et des demandes concernant les médicaments destinés aux humains ou les désinfectants ligne directrice 11 décembre 2017
Ligne directrice : Classification des produits situés à la frontière entre les instruments (médicaux) et les drogues ligne directrice 08 février 2018

 

Mises à jour de Santé Canada (Médicaments, Produits biologiques, Instruments médicaux et Produits de santé naturels et sans ordonnance)

 

Genre de mise à jour et lien Date
Mises à jour : Avis – Utilisation obligatoire du format Electronic Common Technical Document (eCTD) 12 janvier 2017
Avis : L’adoption des lignes directices M7 de l’International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) 19 janvier 2017

 

Jan 22

Communicating with the FDA: Important Changes to Formal Meetings with FDA for PDUFA Products

By: Robert McNeill, Ph.D., Scientist at Cato Research

In December 2017, to address changes under PDUFA VI, the FDA published a draft guidance for industry titled Formal Meetings between the FDA and Sponsors or Applicants of PDUFA Products (Version date: 18 December 2017) (2017 PDUFA Meetings draft guidance). At the same time, two guidance documents were withdrawn: “Formal Meetings between the FDA and Sponsors or Applicants”, published 19 May 2009 and “Formal Meetings between the FDA and Sponsors or Applicants of PDUFA Products”, Revision 2, published 11 March 2015 (2015 PDUFA Meetings draft guidance).

The 2017 PDUFA Meetings draft guidance provides FDA’s recommendations for the formal meetings with the FDA defined under PDUFA VI. As in the previous version, the guidance addresses meetings related to the development and review of drug or biological drug products. This guidance does not apply to abbreviated new drug applications, applications for biosimilar biological products, or submissions for medical devices. Although the 2017 PDUFA Meetings draft guidance is similar to the prior draft guidance, there are some important changes:

Content of meeting requests and meeting packages:

  • Information required to be included in a meeting request is now defined. For example, a list of requested FDA attendees is now required, and justification should be provided for the request of nonessential FDA staff.
  • New details are now recommended to be included in a meeting request and in a meeting package. For example, the proposed regulatory pathway – e.g., 505(b)(1), 505(b)(2) – should now be included in both documents.

Type and format of meetings:

  • There are now four defined meeting types: Type A, Type B, Type B (end of phase [EOP]), and Type C.
  • FDA specifies that any meeting format can be requested for any type of meeting (i.e. face-to-face, videoconference, teleconference, or written response only). This was limited in the previous guidance.
  • Type C meetings can now be held, in some cases, to provide early consultations on the use of a biomarker as a new surrogate endpoint to be used as the primary basis of approval.
  • End-of-phase 2 meetings, pre-phase 3 meetings and certain end-of-phase 1 meetings are now classified as Type B (EOP) meetings, instead of Type B meetings.
  • As always, it remains the FDA’s prerogative to decide whether to grant a meeting, the final meeting type, and the appropriate meeting format, and importantly…
  • FDA advises sponsors and applicants to contact the review division or office to discuss the appropriateness of a Type A meeting request before submitting a meeting request.

Timelines for formal meetings:

Important timelines are nicely summarized in tables within the 2017 PDUFA Meetings draft guidance. Key information and changes include:

  • As before, Type B meetings will be schedule within 60 days of the request with the information package due at least 1 month prior to the meeting.
  • The new Type B (EOP) meetings will be scheduled within 70 days of the request with the information package due at least 50 days prior to the meeting.
  • For Type C meetings to provide consultations on the use of a biomarker as a new surrogate endpoint to be used as the primary basis of approval, the information package must be submitted at the time of the request.
  • For other Type C meetings, the information package must now be submitted at least 47 days before the meeting date (instead of the previous 1 month deadline).
  • Preliminary responses from the FDA should now be sent no later than five days before Type B(EOP) meetings and Type C meetings, instead of at least 2 days before the meeting.
  • The requester will now have to notify the FDA whether Type B (EOP) meetings and Type C meetings meeting are still needed within three days of the meeting.

Other new information

  • More detailed information on the content of FDA’s meeting minutes.
  • A request from CDER to bring desk copies of meeting packages submitted electronically to the meeting.
  • A statement that CBER does not request nor accept desk copies of electronically submitted meeting packages.

The PDUFA Meetings draft guidance 2017 is an essential document for sponsors and applicants when considering formal communications with the FDA. Adhering to these recommendations will help ensure successful and informative meetings with the FDA for drug and biological drug products. This draft guidance is currently open for public comments until 29 March 2018.

Jan 17

South Africa is Transitioning to a New Regulator of Medicines and Medical Devices

By Nicola Main, Clinical Research Manager and Clinical Trial Operations – Rest of World Cato Research, South Africa

 

On 01 June 2017, the President of South Africa proclaimed revisions to the Medicines Act. These provide for the creation of a new regulatory authority, known as the South African Health Products Regulatory Authority (SAHPRA). This new regulator will be responsible for the evaluation and registration of medicines (including complimentary medicines), as well as medical devices and in-vitro diagnostics. The Authority will also ensure that clinical trial protocols are being assessed according to prescribed ethical and professional criteria and defined standards.

 

A government notice requesting nominations for the Board of SAHPRA was published on 06 June 2017 and on 09 October 2017 the Minister of Health published the names of the 15 members of the Board. (The Minister of Health appoints the Board members of SAHPRA, and SAHPRA acts through its Board.) The Board have been appointed for a 3 year term of office, expiring on 30 September 2020.

 

Although the Board has been appointed, a number of items need to take place before the SAHPRA formally take over from the current regulator, the Medicines Control Council (MCC). Some of these are described in Section 26 (Transitional Arrangements) of Act 14 of 2015 (which also came into operation when Act 72 of 2008 was proclaimed) and include the transition of staff, movable property and pending registration applications. In addition to these Transitional Arrangements, another key step is for the Treasury to formally approve SAHPRA as a Section 3a Public Entity. so that it can retain revenue*.

 

As SAHPRA will have the power to retain the registration and clinical trials application fees, as well as other fees, it generates and is allowed to remunerate staff at rates higher than those typically paid in the public service, it is expected that this will enhance its ability to attract and retain staff. The State, through the Department of Health, is expected to fund SAHPRA initially but the Authority is ultimately expected to secure 70% of its budget from fees.

 

The MCC will continue to exist and carry out its functions until the day before the first meeting of the SAHPRA. This meeting will be on a date determined by the Minister of Health but is largely expected to be in the first quarter of 2018. As described in the Transitional Arrangements, all previous decisions, guidelines and procedures that are within the scope of the SAHPRA’s functions, and which are in force on the day of the first Board meeting date will remain in force until they are amended or repealed by the SAHPRA.

 

*A Section 3A Public Entity (or national government business enterprise) is normally an extension of a public entity with the mandate to fulfil a specific economic or social responsibility of government. It relies on government funding and public money. Examples are the South African Revenue Service, South African National Parks and National Health Laboratory Service.

 

Jan 05

New FDA Guidances for December 2017

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 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

Special Interest Guidances/Information Date Posted
Labeling for Combined Hormonal Contraceptives – Draft Guidance 29 Dec 2017
Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry – Final Guidance 28 Dec 2017
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products – Draft Guidance 28 Dec 2017
Best Practices for Communication Between IND Sponsors and FDA During Drug Development – Final Guidance 28 Dec 2017
Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers – Draft Guidance 26 Dec 2017
Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products– Draft Guidance 21 Dec 2017
Amendment to Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products – Draft Guidance 21 Dec 2017
Medical Device Accessories – Describing Accessories and Classification Pathways – Final Guidance 20 Dec 2017
Clarification of Orphan Designation of Drugs and Biologics for Pediatrics – Draft Guidance 19 Dec 2017
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices – Draft Guidance 19 Dec 2017
Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research – Draft Guidance 18 Dec 2017
Drug Products Labeled as Homeopathic – Draft Guidance 18 Dec 2017
Investigational IVDs Used in Clinical Investigations of Therapeutic Products – Draft Guidance 18 Dec 2017
Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease – Draft Guidance 15 Dec 2017
Drug Products, Including Biological Products, that Contain Nanomaterials – Draft Guidance 15 Dec 2017
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments – Draft Guidance 15 Dec 2017
The Least Burdensome Provisions: Concept and Principles – Draft Guidance 15 Dec 2017
An Acceptable Circular of Information for the Use of Human Blood and Blood Components – Final Guidance 14 Dec 2017
Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs – Final Guidance 13 Dec 2017
Gluten in Drug Products and Associated Labeling Recommendations – Draft Guidance 12 Dec 2017
Refuse to File: NDA and BLA Submissions to CDER – Draft Guidance 12 Dec 2017
Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use – Final Guidance 12 Dec 2017
Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling – Final Guidance 11 Dec 2017
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act – Draft Guidance 08 Dec 2017
Software as a Medical Device (SAMD): Clinical Evaluation – Final Guidance 08 Dec 2017
Clinical and Patient Decision Support Software – Draft Guidance 08 Dec 2017
Pediatric Rare Diseases–A Collaborative Approach for Drug Development Using Gaucher Disease as a Model – Draft Guidance 06 Dec 2017
Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components – Final Guidance 05 Dec 2017
FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions – Final Guidance 05 Dec 2017
Technical Considerations for Additive Manufactured Medical Devices – Final Guidance 05 Dec 2017
Providing Regulatory Submissions in Electronic Format – Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling – Draft Guidance 01 Sep 2017
Upcoming Meetings (* = New)
* January 9, 2018: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee
* January 10, 2018: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee
* January 11, 2018: Meeting of the Antimicrobial Drugs Advisory Committee
* January 24, 2018: Tobacco Products Scientific Advisory Committee
* March 1, 2018: Neurological Devices Panel of the Medical Devices Advisory Committee
Last updated: 02 January 2018

 

Dec 22

What’s New Health Canada?

By Amelie Rodrigue-Way, PhD, 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
Quality (Chemistry and Manufacturing): New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) Guidance 30 October 2017
Addendum – Quality (Chemistry and Manufacturing) Guidance: Questions and Answers Guidance 30 October 2017
Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference Product Guidance 27 November 2017

 

Updates from Health Canada (Drugs and Biologics) 

Type of Update and Link Date Posted
Notice – Validation rules for regulatory transactions submitted to Health Canada in the electronic Common Technical Document (eCTD) format 27 November 2017

 

   

Santé Canada: Quoi de neuf?

Par Amelie Rodrigue-Way, PhD, RAC(CAN), Associate Director, Regulatory Strategy

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
Ligne directrice sur le document certifié d’information sur les produits – Entités chimiques ligne directrice 30 octobre 2017
Addenda – Qualité (chimie et fabrication) : Questions et réponses ligne directrice 30 octobre 2017
ligne directrice Utilisation d’un produit de référence étranger comme produit de référence canadien ligne directrice 27 novembre 2017

 

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 soumises par Santé Canada en format electronic Common Technical Document (eCTD) [ 27 novembre 2017

 

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