AG/FDA Blog

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!… 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 bu… 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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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This morning, FDA met another of its milestones in implementing the Drug Supply Chain Security Act (DSCSA) and posted a Draft Guidance, DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription… Read More
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Consumer-Directed Promotions About Prescription Drugs: A Look Back at Print and TV Communications

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part VI) By Tish Eggleston Pahl In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are ta… 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 ta… Read More
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The Realized Benefits of User Fees

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part III) In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to sha… 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 interes… Read More
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FDA was Busy in 2013 and its Sleigh is Packed Heading into the New Year

While often rightly the subject of criticism for delay or inaction on important regulatory matters, FDA in late 2013 has been bustling.  The FDA, during the second Obama term, has been pursuing a very aggressive regulatory agenda.  In addition to 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 Qu… Read More
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