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Sheppard Mullin Richter & Hampton LLP

Location Matters – Manufacturing Insights from FDA’s Annual Report on Drug Quality

Sheppard Mullin Richter & Hampton LLP on

The Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) within the US Food and drug Administration (FDA) published its annual “Report on the Sate of Pharmaceutical Quality” last week....more

BakerHostetler

FDA Launches DSCSA Pilot Project Program, Supports Use of Blockchain Technology

BakerHostetler on

On Feb. 7, 2019, the U.S. Food and Drug Administration (FDA) published a press release and on the following day published an accompanying notice in the Federal Register announcing a Pilot Project Program Under the Drug Supply...more

Hogan Lovells

FDA finalizes two guidances clarifying DSCSA enforcement exemptions and issues product identifier Q&A

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) finalized two important Drug Supply Chain Security Act (DSCSA)-related guidances that aim to help pharmaceutical trading partners understand their compliance obligations...more

Mintz - Health Care Viewpoints

FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements

Mintz - Health Care Viewpoints on

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post,...more

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