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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...

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...

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Recent Posts

Continual Improvement Process

  • Thursday, March 28, 2019

Reducing Validation Costs – What’s the Most Effective Way?

  • Tuesday, June 5, 2018

Got the interview? Now time to get the job!

  • Wednesday, March 7, 2018

Establishing a Successful Data Integrity Management Culture

  • Tuesday, August 29, 2017

Is Over Regulation Stifling Innovation?

  • Wednesday, April 19, 2017

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