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Mar 04 2020

New FDA Gudiances for February 2020 and Upcoming Advisory Committee Meetings

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS

 

 Special Interest Guidances/Information Date Posted
Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff – Final Guidance 29 Feb 2020
CVM GFI #264 Standardized Medicated Feed Assay Limits – Draft Guidance 27 Feb 2020
Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 26 Feb 2020
Recommendations for Dual 510(k) and CLIA Waiver by Application Studies: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 26 Feb 2020
Product Labeling for Laparoscopic Power Morcellators: Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 26 Feb 2020
CVM GFI #191 Changes to Approved NADAs – New NADAs vs. Category II Supplemental NADAs – Final Guidance 21 Feb 2020
Guidance for Industry: FDA’s Voluntary Qualified Importer Program – Final Guidance 21 Feb 2020
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry – Final Guidance 21 Feb 2020
Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments – Final Guidance 14 Feb 2020
CVM GFI #262 Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices – Draft Guidance 13 Feb 2020
Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration – Draft Guidance 13 Feb 2020
Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 13 Feb 2020
Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry: Draft Guidance for Industry – Draft Guidance 6 Feb 2020
Withdrawn CDER Product Specific Guidances – Final Guidance 5 Feb 2020
Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II): Guidance for Industry – Final Guidance 5 Feb 2020
Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment Guidance for Industry: Draft Guidance for Industy – Draft Guidance 4 Feb 2020
Small Entity Compliance Guide: Revision of the Nutrition and Supplement Facts Labels – Final Guidance 3 Feb 2020
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry – Draft Guidance 3 Feb 2020
Chapter 53 – 7353.001c Risk Evaluation and Mitigation Strategies – Final Guidance 1 Feb 2020
Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims – Final Guidance 30 Jan 2020

 

Upcoming Meetings (* = New)
  March 4, 2020: Vaccines and Related Biological Products Advisory Committee Meeting
* March 11, 2020: Nonprescription Drugs Advisory Committee
* April 2-3, 2020: Blood Products Advisory Committee
* April 21, 2020: Pulmonary-Allergy Drugs Advisory Committee
* April 23, 2020: Medical Imaging Drugs Advisory Committee
* April 23-24, 2020: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
* May 15, 2020: Allergenic Products Advisory Committee

Last updated: 04 March 2020