FDA Stakeholder Update - May 29, 2020

Updates

May 28, 2020 - Daily Roundup May 28, 2020 - CDER: Remdesivir Spanish Q&A update  May 27, 2020 - Daily Roundup May 27, 2020 - FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection May 26, 2020 - Daily Roundup

Request for Comments

May 28, 2020 - Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised): The FDA is issuing this guidance to assist persons submitting cigarette plans for cigarette packages and cigarette advertisements, as required by the Family Smoking Prevention and Tobacco Control Act, amending the Federal Cigarette Labeling and Advertising Act (FCLAA). May 28, 2020 - Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised): Guidance for Industry: FDA is issuing this guidance to help small businesses understand and comply with FDA’s final rule, which establishes new required cigarette health warnings for cigarette packages and advertisements. The final rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. May 27, 2020 - Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency: Guidance for Industry: The FDA is issuing this guidance to provide certain FDA-regulated food establishments (i.e., human food facilities and farms, but not restaurants and retail food establishments), with a convenient mechanism to voluntarily report to FDA if they have temporarily ceased or significantly reduced production or if they are considering doing so.   May 26, 2020 - Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications - Questions and Answers: This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration (FDA or Agency) has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)).

For a more comprehensive list of all official FDA Guidance Documents and other regulatory guidances, please visit here.

Webinars and Virtual Workshops

Webcast Lecture: Streamlining Genetic Safety Analysis for Ex Vivo Genome Edited Cell Therapies Genome editing is an emerging and exciting new technology that is being discussed as a potential method to treat a range of diseases that have large unmet medical needs. This lecture will discuss the process of generating data to assess which methods of identifying potential off-target sites using the CRISPR/Cas9 system identify bona fide off-target sites using clinically relevant ex vivo genome editing reagents. Date: June 2, 2020   Time: 3:00 PM - 4:00 PM ET Registration is not required.

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests

The FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.

Date: June 3, 2020    Time: 12:15 PM - 1:15 PM ET

Registration is not required.

Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice Web Conference - Organized by FDA in Collaboration with the Clinical Trials Transformation Initiative (CTTI) This stakeholder engagement web conference will inform the discussions of the ICH Expert Working Group (EWG), which is tasked with updating the guideline and making it more responsive to advances in clinical trial design and conduct. Members of the EWG will provide an overview of the ongoing work to update the guideline and will then hear from multiple stakeholders on their experiences with ICH E6(R2). Date: June 4 - 5, 2020    Time: 10:00 AM - 1:00 PM ET To register for this Web Conference, please visit the registration page.

Register Here

Safety Information

FDA Alerts Patients and Health Care Professionals to Nitrosamine Impurity Findings in Certain Metformin Extended-Release Products The FDA announced that agency laboratory testing has revealed levels of the nitrosamine impurity N-Nitrosodimethylamine (NDMA) above the agency’s acceptable intake limit in several lots of the extended-release (ER) formulation of metformin, a prescription drug used to control high blood sugar in patients with type 2 diabetes. The agency is in contact with five firms to recommend they voluntarily recall their products. Company recall notices will be posted on FDA’s website .