Availability of Regulatory Management Plans | FDA

Availability of Regulatory Management Plans | FDA

Information for industry

• FDA published a new web page, Availability of Regulatory Management Plans. The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as amended by the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA), furthered FDA’s mission of fostering the development and availability of medical countermeasures (MCMs) by codifying the development of Regulatory Management Plans (RMPs) for certain high-priority MCMs. Under section 565(f) of the Federal Food, Drug, and Cosmetic (FD&C) Act, sponsors or applicants of eligible MCMs can request an RMP, setting forth a formal process for obtaining scientific feedback and agency interactions regarding the development and regulatory review of eligible MCMs. This page provides information about RMPs for MCM sponsors or applicants. Also see: MCM-Related Counterterrorism Legislation (December 6, 2019)
• Draft guidance - Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff - Provides FDA’s current thinking regarding the qualification process for drug development tools (DDTs) for a specific use, as defined in the 21st Century Cures Act. Qualification is a voluntary process that permits use of a DDT for its context of use— the defined boundaries within which the available data justifies use of the DDT(s)—across multiple drug development programs. DDTs are methods, materials, or measures that have the potential to facilitate drug development, including, for example, an animal model used for efficacy testing of medical countermeasures under the Animal Rule. Comment by February 12, 2020. (December 13, 2019)
• FDA issued a final rule, Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Required in Electronic Format. The new rule requires medical device premarket submissions to be sent in electronic format, eliminating the need for multiple paper submissions. FDA is also publishing a revised eCopy Guidance, eCopy Program for Medical Device Submissions. The update to the eCopy guidance reflects the amendments to the regulations. (December 13, 2019)