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FDA issues draft guidance on device changes that warrant new premarket review

The U.S. Food and Drug Administration today issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.

Foodborne outbreak potentially associated with papaya distributed by Agromod Produce, Inc.

The FDA is taking steps to protect the public following the identification of Salmonella Agona in Agromod Produce, Inc.’s supply of fresh papayas. The FDA is advising consumers not to eat papayas from Agromod Produce, Inc. The company is voluntarily recalling the...

FDA Center for Drug Evaluation and Research develops strategic science and research agenda

A U.S. Food and Drug Administration report from its Center for Drug Evaluation and Research (CDER), available today in the Federal Register, identifies the current regulatory science needs that will guide CDER’s strategic planning of internal research initiatives and...

TigerTox: Hitting Leadoff in #Biotech http://bit.ly/Pharma101Logic. Excellent insights! #in #pharma

TigerTox: Hitting Leadoff in #Biotech http://bit.ly/Pharma101Logic. Excellent insights! #in #pharma

TigerTox: Survey – Most #Pharmaceutical Execs Foresee More M&A – NYTimes.com http://nyti.ms/PharmaOutlookTo2014 #in

TigerTox: Survey – Most #Pharmaceutical Execs Foresee More M&A – NYTimes.com http://nyti.ms/PharmaOutlookTo2014 #in
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