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FDANonrulemakingFDA-2014-D-0779

Draft Guidance for Industry on Current Good Manufacturing Practice — Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act; Availability

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Association for Accessible Medicines filings
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Association for Accessible Medicines filed 1 comment on this docket between Feb 12, 2019 and Feb 12, 2019. 0 other organizations filed here. The comment window closed 2724d ago.

What Association for Accessible Medicines filed (1)

Feb 12, 2019· Comment from Association for Accessible Medicines· FDA-2014-D-0779-0028

The Association for Accessible Medicines (AAM) is pleased to provide comments on the Food and Drug Administrations (FDAs or the Agencys) revised draft guidance, Current Good Manufacturing PracticeGuidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.

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Draft Guidance for Industry on Current Good Manufacturing Practice — Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act; Availability (FDA) — Association for Accessible Medicines | OpenPolis