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May 10

New FDA Guidance’s for April 2019

Special Interest Guidances/Information Date Posted
Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 26 Apr 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 26 Apr 2019
Unique Device Identification: Convenience Kits : Guidance for Industry and Food and Drug Administration Staff – Final Guidance 26 Apr 2019
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes Guidance for Industry – Draft Guidance 24 Apr 2019
Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles – Final Guidance 24 Apr 2019
Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff – Draft Guidance 24 Apr 2019
Surgical Staplers and Staples for Internal Use – Labeling Recommendations: Draft Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 24 Apr 2019
Compliance Policy for Combination Product Postmarketing Safety Reporting: Immediately in Effect Guidance for Industry and Food and Drug Administration Staff – Final Guidance 21 Apr 2019
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol: Draft Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 19 Apr 2019
Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions: Draft Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 19 Apr 2019
Bispecific Antibody Development Programs Guidance for Industry – Draft Guidance 18 Apr 2019
Draft Guidance for Industry: The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels – Draft Guidance 17 Apr 2019
1988 FDA Guidance for the Format and Content of the Clinical and Statistical Section of an Application – Final Guidance 13 Apr 2019
FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary – Final Guidance 4 Apr 2019
Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection: Guideline for Industry and Food and Drug Administration Staff – Final Guidance 1 Apr 2019
Review and Update of Device Establishment Inspection Processes and Standards: Draft Draft Guidance for Industry – Draft Guidance 29 Mar 2019
CVM GFI #120 Veterinary Feed Directive Regulation Questions and Answers – Draft Guidance 28 Mar 2019
Guidance for Industry: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds – Final Guidance 27 Mar 2019
Upcoming Meetings (* = New)
* May 14, 2019: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
* May 30-31, 2019: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
* June 6, 2019: Antimicrobial Drugs Advisory Committee Meeting Announcement
* June 11-12, 2019: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee
* June 19-20, 2019: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
* June 20, 2019: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

 

Last updated: 09 May 2019