Wave of Warning Letters to Foreign OTC Drug Manufacturing Facilities Following Remote Records Requests
FDA Law Blog
AUGUST 10, 2023
Instead, FDA issued a request for records pursuant to Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FDCA). Section 704(a)(4) was added to the FDCA by the Food and Drug Administration Safety and Innovation Action (FDASIA) in July 2012.
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