AG/FDA Blog

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 devi… 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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HIPAA, the TCPA and Robodialing

Over the past several months, we have received several questions regarding how HIPAA interacts with the FCC’s implementation of rules under the Telephone Consumer Protection Act (TCPA).  Specific questions center around when authorization may be r… Read More
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What’s New at CDRH?

Since January 1, it seems that the Center for Devices and Radiological Health (CDRH) has been out of the agency’s spotlight, and even FDA’s “News & Events” webpage has been lacking in its reporting of medical device related activity.  Th… Read More
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FDA Margin Call On Off-Label Promotion

FDA’s Office of Prescription Drug Promotion (OPDP) just issued a warning letter to the CEO of Aegerion Pharmaceuticals Inc. (Aegerion) for making unapproved drug claims during two television interviews on CNBC.  FDA says Aegerion CEO, Marc Beer, o… Read More
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