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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...

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...

Unified Agenda – Regulations the FDA is Planning to Issue

  • Friday, July 12, 2013

The FDA has published a list of upcoming regulations it plans to issue in the next year. The complete list is available here. Of these regulations, following is a list that will have relevance for the pharmaceutical and me...

Final Rule on GMP Requirements for Combination Products

  • Monday, June 10, 2013

At long last, the final rule on good manufacturing practice (GMP) requirements for combination products will be published in the January 22, 2013 Federal Register. An advanced display copy of the final rule is available at...

Cork Chamber of Commerce Annual Conference 2013 – Winning in the UK & Beyond

  • Wednesday, June 5, 2013

The Cork Chamber of Commerce held its Annual Conference this week at the scenic Fota Island Resort. The theme for this years’ conference was “Winning in the UK & Beyond”. I attended along with GxP Systems Business Developm...

Changing Role of Manufacturing Key Topic at Cork Electrical Industry Association’s Annual Conference

  • Tuesday, May 28, 2013

I recently joined GxP Systems MD Linda Mellerick at the Cork Electrical Industry Association’s Annual Conference at the Radisson SAS Hotel, Little Island, Cork. The theme for this year’s conference was “The Changing Role o...

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