GXP Systems


New FDA Guidance Modifies 510(k) Rules

  • Tuesday, September 2, 2014

On 28th July 2014, the FDA announced in a new final guidance a change in its approach to multiple predicate devices in 510(k) submissions and will no longer clear these devices because of the potential to cause long term d...

Global Unique Device Identification Database (GUDID)

  • Friday, August 29, 2014

In September 2013, the FDA published the Final Unique Device Identifier (UDI) Regulation, which we discussed in detail in one of our earlier blogs. UDI initiatives also are underway globally; the European Commission releas...

Final Rule from FDA on Infant Formula Current Good Manufacturing Practices

  • Thursday, August 21, 2014

In June 2014, the FDA published its final rule on current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula. It is in effect f...

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In June 2014, the FDA published a draft guidance intending to aid manufacturers, re-packagers, distributors or dispensers in identifying a suspect product and terminating notifications regarding illegitimate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

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