FDA Releases Draft Guidance on Compounding Animal Drugs

Yesterday, FDA released a Draft Guidance for Industry on Compounding Animal Drugs from Bulk Drug Substances (Draft Guidance). The Federal Register notice accompanying the Draft Guidance can be found here. The agency also withdrew its previous Complia… Read More
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26 Years, With 9 To Go.... 35 Years to Prescription Drug Traceability

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part IV) By Tish Eggleston Pahl In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are tak… Read More
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OFW Law’s MMXIII in Retrospect

As MMXIV starts, it’s time for a retrospective look at MMXIII. What follows is a list of noteworthy events from MMXIII in our food, drug, medical device, and agriculture corner of the universe, focusing on matters that were of particular interest t… Read More
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And They’re Off! FDA Wastes No Time in Implementing its New Compounding Authority

It appears that FDA, like many of us, anticipated the passage of the Drug Quality and Security Act (DQSA) (H.R. 3204). We previously blogged about Title II of the DQSA here, which focused on drug supply chain security. Title I, the Compounding Qualit… Read More
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Achievement Unlocked! Senate Passes Drug Quality and Security Act for a Safer, More Secure Pharmaceutical Supply Chain

In a time when internecine conflicts within the Congress and between the legislative and executive branch stymie so much important work, the easy passage of the bipartisan Drug Quality and Security Act (DQSA) (H.R. 3204) is cause for celebration. Hav… Read More
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