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

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our. ....

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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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