AG/FDA Blog

FDA Drug Promotion Enforcement Update

It has been an interesting week from the perspective of an FDA drug promotion attorney. On the one hand, we have a federal district court expanding how drug companies can promote drugs; on the other, we have FDA’s Office of Prescription Drug Promot… Read More
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FDA Releases Draft Guidance on Compounding Animal Drugs

Yesterday, FDA released a Draft Guidance for Industry on Compounding Animal Drugs from Bulk Drug Substances (Draft Guidance). The Federal Register notice accompanying the Draft Guidance can be found here.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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May 19 Webinar on the Drug Supply Chain Security Act

Tish Eggleston Pahl will be speaking on May 19 at a webinar on dispenser obligations under the Drug Supply Chain Security Act (DSCSA). The webinar is sponsored by the Healthcare Distribution Management Association (HDMA). This “DSCSA Overview for D… Read More
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Webinar: Drug Supply Chain Security Act Overview for Dispensers

On April 21, OFW Law’s Tish Eggleston Pahl will participate in a webinar being held by the Healthcare Distribution Management Association (HDMA) for dispensers on implementation of the Drug Supply Chain Security Act (DSCSA) Register Today! Lear… Read More
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Drug Supply Chain Security Act – What’s Next? A whole lot.

The passage of the Drug Supply Chain Security Act (DSCSA) in November 2013 led to a very busy 2014 as FDA and manufacturers, wholesale distributors, and dispensers began the statute’s complex 10-year implementation. 2015 promises to be equally busy… Read More
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2014 And 2015

As we say goodbye to 2014 and welcome 2015, it’s time for a little backward and forward looking. Here’s what we saw in the 2014 rear view mirror in our little corner of the Universe devoted to the regulatory aspects of foods, drugs, medical devic… Read More
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FDA’s Draft Guidance On DSCSA Preemption Misses The Mark

In a flurry of end-of-year activity, FDA recently issued a Draft Guidance on the express preemption provisions in §585 of the FDC Act, added last year by the Drug Supply Chain Security Act (or DSCSA). FDA, the pharmaceutical supply chain, and other… Read More
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Webinar Tomorrow: What Dispensers Need to Know About the Drug Supply Chain Security Act

A Complimentary Webinar Presented by OFW Law’s Tish Pahl and the Food Marketing Institute Thursday, December 4th, 2014 3:00 pm – 4:00 pm US/Eastern Please join FMI on a webinar with Tish Pahl —Under the Drug Supply Chain Security Act (D… Read More
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FDA Opens Portal For Wholesale Distributor and 3PL Reporting

While you were sitting in traffic, making pie crust, or absorbing the menu and vending labeling rules… FDA Opens Portal For Wholesale Distributor and 3PL Reporting At OFW Law, we hope you all had a terrific Thanksgiving. (If you followed the advice… Read More
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The DSCSA Standards Guidance is here!

This morning, FDA met another of its milestones in implementing the Drug Supply Chain Security Act (DSCSA) and posted a Draft Guidance, DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription… Read More
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