By Sheila Plant, PhD, RAC, Senior Director, Regulatory Affairs at CATO SMS

 Special Interest Guidances/Information Date Posted
Providing Regulatory Submissions in Electronic Format — Standardized Study Data 29 October 2020
Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry 28 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 Staff 28 October 2020
Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date: Guidance for Industry, Stakeholders, Health Care Professionals, and Food and Drug Administration Staff 28 October 2020
Referencing Approved Drug Products in ANDA Submissions Guidance for Industry 27 October 2020
Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies 27 October 2020
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies 22 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Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry: Draft Guidance for Industry 20 October 2020
Guidance for Industry: The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels 16 October 2020
Guidance for Industry: U.S. Agent Voluntary Identification System (VIS) for Food Facility Registration 16 October 2020
Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry 16 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 Industry 16 October 2020
Testing for Biotin Interference in In Vitro Diagnostic Devices: Guidance for Industry 15 October 2020
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol: Guidance for Industry and Food and Drug Administration Staff 15 October 2020
Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin: Draft Guidance for Industry and Food and Drug Administration Staff 15 October 2020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 Staff 13 October 2020
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment: Draft Guidance for Industry 07 October 2020
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment Guidance for Industry 01 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 Industry 01 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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