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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Submission of Plans for Cigarette Packages and Cigarette Advertisements – Draft Guidance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Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry – Draft Guidance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Requesting FDA Feedback on Combination Products : Draft Guidance for Industry and FDA Staff – Draft Guidance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Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry – Draft Guidance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Bridging for Drug-Device and Biologic-Device Combination Products: Draft Guidance for Industry – Draft Guidance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)

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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

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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

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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