FDA’s Recommended 2/15/22 Reporting Date for 2020 Amounts of Listed Drugs and Biological Products is Non-binding and Not a Requirement

The draft guidance document is not a binding document, and the recommended 2/15/22 reporting date for 2020 data is not a requirement.

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . FDA's Recommended 2/15/22 Reporting Date for 2020 Amounts of Listed Drugs and Biological Products is Non-binding and Not a Requirement   FDA is considering comments to our draft guidance on Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act, including comments about the recommended timelines for submitting the required reports. The draft guidance document is not a binding document, and the recommended February 15, 2022 reporting date for 2020 data is not a requirement. We are carefully reviewing all issues raised by stakeholder comments to the docket, including regarding the recommended reporting timeframes. We will consider updating the draft guidance's recommended timeframes for reporting, as appropriate, along with other issues raised by such stakeholder feedback.   Learn More The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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