Emerging Issues and Cross-Cutting Scientific Advances - FDA; Establishment of a Public Docket - Federal Register

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Go to the full notice: Federal Register :: Emerging Issues and Cross-Cutting Scientific Advances; Establishment of a Public Docket - FDA:

"The Food and Drug Administration (FDA) is establishing a public docket to receive input on emerging issues and cross-cutting scientific advances that may impact FDA preparedness and inter-Agency activities. Interested parties are invited to submit comments regarding emerging technologies and cross-cutting scientific advances of importance to FDA. The focus is on areas that may impact FDA in 5 or more years."

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FDA to Drug Compounders: Inspection Changes Coming in August | RAPS

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Updated October 8, 2022

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Human Drug Compounding - FDA.gov

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Read the full article: FDA to Drug Compounders: Inspection Changes Coming in August | RAPS:

"For companies that compound human drugs in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (i.e., human drug compounders that are not registered with FDA as outsourcing facilities under section 503B), effective 1 August 2016, “FDA investigators will make a preliminary assessment of whether such entities are compounding their human drugs in accordance with certain conditions of section 503A before closing the inspection.”"

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Read the details of the FDA Notice (PDF)

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