New FDA Guidance for October 2020 and Upcoming Advisory Committee Meetings

 Special Interest Guidances/InformationDate Posted
Providing Regulatory Submissions in Electronic Format — Standardized Study Data29 October 2020
Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry28 October 2020
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised): Guidance for Industry and Food and Drug Administration Staff28 October 2020
Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date: Guidance for Industry, Stakeholders, Health Care Professionals, and Food and Drug Administration Staff28 October 2020
Referencing Approved Drug Products in ANDA Submissions Guidance for Industry27 October 2020
Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies27 October 2020
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies22 October 2020
Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry: Draft Guidance for Industry20 October 2020
Guidance for Industry: The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels16 October 2020
Guidance for Industry: U.S. Agent Voluntary Identification System (VIS) for Food Facility Registration16 October 2020
Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry16 October 2020
FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements: Guidance for Industry16 October 2020
Testing for Biotin Interference in In Vitro Diagnostic Devices: Guidance for Industry15 October 2020
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol: Guidance for Industry and Food and Drug Administration Staff15 October 2020
Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin: Draft Guidance for Industry and Food and Drug Administration Staff15 October 2020
Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff13 October 2020
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment: Draft Guidance for Industry07 October 2020
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment Guidance for Industry01 October 2020
Importation of Certain FDA- Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry01 October 2020
Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment: Draft Guidance for Industry01 October 2020
Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment: Draft Guidance for Industry01 October 2020
Upcoming Meetings (* = New)
*Nov 6, 2020: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting
*Nov 9, 2020: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
*Dec 15, 2020: Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
*Dec 16, 2020: Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement

Last updated: 03 November 2020

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