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Enforcement Drug Compounding

Gardner Law

FDA’s Center for Drug Evaluation and Research (CDER) Issues FY2023 Annual Report

Gardner Law on

In January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of information for drug companies and...more

BakerHostetler

Stop the Presses! Senate Directs FDA to Meet With Stakeholders Before Enforcing Compounding Law

BakerHostetler on

As previously discussed, the recent flurry of U.S. Food and Drug Administration (FDA) activity following passage of the Drug Quality and Security Act (DQSA) in November 2013, including the issuance of three draft guidance...more

K&L Gates LLP

Makena Drug Compounding Lawsuit Against FDA Gets New Life

K&L Gates LLP on

On January 7, 2014, a three-judge panel of the United States Circuit Court for the District of Columbia unanimously vacated the dismissal of claims against the U.S. Food and Drug Administration (“FDA”) and others by K-V...more

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