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AGG Food & Drug Newsletter - April 2021 | Arnall Golden Gregory LLP

Federal
Register notice finally announcing the fee rates under the Over-the-Counter (OTC) Monograph Drug User Fee Program for Fiscal Year 2021. As we discussed in a previous Bulletin, the CARES Act, among other things, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow FDA to assess and collect user fees from qualifying owners of OTC monograph drug facilities and qualifying submitters of OTC monograph order requests (OMORs). The fees are meant to support FDA in its OTC monograph drug activities, including inspections of facilities associated with such products. More >
Arbitration as an Alternative to the Backlogged Courts ....

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See Me, Feel Me: FDA Gives Guidance on Remote Interactive Evaluations of Drug Facilities During COVID-19 | Arnall Golden Gregory LLP

Channeling The Who’s
Tommy Soundtrack and the classic song “See Me, Feel Me,” the Food and Drug Administration issued a guidance document, “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency.”
1 The facilities covered are those that manufacture pharmaceutical and biological products, those covered under the agency’s Bioresearch Monitoring Program, and outsourcing facilities registered under Section 503B of the Federal, Food, Drug and Cosmetic Act.
This Bulletin highlights some of the key points described in the guidance.
A facility is not required to accept FDA’s request to conduct a remote facility evaluation. It may decline the request. However, the agency notes that the decision may, as a result, delay its ability to evaluate the company’s facility or product, which can affect a timely regulatory decision on other matters, such as application review and appro ....

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