GXP Systems


Drug Supply Chain Security Act Implementation: Draft FDA Guidance

  • Saturday, August 16, 2014

In June 2014, the FDA published a draft guidance intending to aid manufacturers, re-packagers, distributors or dispensers in identifying a suspect product and terminating notifications regarding illegitimate products. With...

Medical Device Tracking - Guidance for Industry and Food and Drug Administration Staff

  • Thursday, April 10, 2014

On 28th March 2014, the FDA published a Guidance for Industry and FDA Administration Staff on Medical Device Tracking, superseding the previous guidance issued in 2010. It represents the FDA’s current thinking on this topi...

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...

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...

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