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FDA is withdrawing temporary policies for manufacturers that were not drug manufacturers to produce hand sanitizers during the PHE. Effective December 31, 2021, companies manufacturing alcohol-based hand sanitizers relying on these policies must cease production of products.
On Tuesday, October 12, 2021, the US Food and Drug Administration (FDA) announced that it will withdraw the temporary policies originally issued in March 2020 for manufacturers that...
Certifying Pharmaceutical Exports: An Introduction To FDA's Certificate Of Pharmaceutical Product By Michael Cooper, Clinical and Regulatory Affairs, Pharmatech Associates When exporting human drugs, manufacturing facilities are often asked by foreign customers or governments to provide documentation of the facility’s compliance with FDA standards. FDA issues export certificates for approved or licensed drugs and for unapproved drugs that meet certain legal requirements. Certificates of pharmaceutical product (CPP) are issued for human drugs exported from the U.S. directly to the requestin...
Originally published on December 30, 2020, this article was last updated on January 6, 2021. On January 4, 2021, FDA unexpectedly withdrew the notice entitled Fee Rates Under the Over the Counter Monograph User Fee Program for Fiscal Year 2021 stating that it had been ordered to cease further collection efforts pending approval from the Secretary of the Department of Health and Human Services (HHS). The withdrawal notice states that the original notice issued without such Secretarial approval. Under the CARES Act, the Secretary is required to establish and collect OTC drug manufacturer fac...