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The Special 510(k) Program – Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance

Adaptive Design Clinical Trials for Drugs and Biologics – Draft Guidance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Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry – Draft Guidance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Analyses and Human Factors Submissions to Drug and Biologic Applications Guidance for Industry and FDA Staff – Draft Guidance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Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls – Draft Guidance 26 Sep 2018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Insanitary Conditions at Compounding Facilities Guidance for Industry – Draft Guidance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Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications – Draft Guidance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Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank – Draft Guidance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