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FDA and European Medicines Agency Strengthen Collaboration in Pharmacovigilance Area

  • Tuesday, February 25, 2014

The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have set-up a new 'cluster' on pharmacovigilance (medicine safety) topics. Clusters are regular collaborative meetings between the EMA and regul...

FDA Initiates Secure Supply Chain Pilot Program to Enhance Security of Imported Drugs

  • Monday, February 24, 2014

The U.S. Food and Drug Administration is announcing the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. In August 2013, the FDA published a notice in the Federal Register (78 ...

New & Revised Draft Guidances CDER is Planning to Publish During 2014

  • Friday, February 14, 2014

The FDA recently published a list of draft guidances that CDER (Center for Drug Evaluation and Research) is planning to publish during 2014. Here is a list of guidances that we think will be particularly interesting. CATE...

Medical Device Single Audit Program

  • Friday, November 15, 2013

This notice appears in today's Federal Register with more information about the IMDRF Medical Device Single Audit Program (MDSAP). http://www.ofr.gov/OFRUpload/OFRData/2013-27358_PI.pdf As explained in the notice, the MD...

International Inspections & FDA 483s on the Rise

  • Thursday, August 15, 2013

An interesting article from FDAzilla alerts non-U.S. pharmaceutical plants to the increase in the number of FDA inspections, and the difference in inspection standards for foreign and U.S. companies. The FDA is rapidly sc...

Further Analysis of New MDR Reporting Guidance

  • Monday, July 15, 2013

Further to our previous blog entry, we can now provide additional analysis of the new MDR Reporting guidance issued by the FDA last week. You can find a link to the guidancehere. The draft guidance takes a question/answer...

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