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PDA/FDA

Non-Compendial Product Quality Screening Draws US FDA’s Criticism

Non-Compendial Product Quality Screening Draws US FDA’s Criticism

 
• By Bowman Cox

Third-party screening of US-marketed drug products is worse than pointless if done with subpar test methods, agency tells PDA/FDA meeting. Meanwhile, release-testing with such methods has been triggering warning letters.

Non-Compendial Product Quality Screening Draws US FDA’s Criticism

Non-Compendial Product Quality Screening Draws US FDA’s Criticism

 
• By Bowman Cox

Third-party screening of US-marketed drug products is worse than pointless if done with subpar test methods, agency tells PDA/FDA meeting. Meanwhile, release-testing with such methods has been triggering warning letters.

Can We Talk? US FDA Remote Records Review Missteps Worry Industry

Can We Talk? US FDA Remote Records Review Missteps Worry Industry

 
• By Bowman Cox

Alkermes CRL is just the latest fallout from black-hole process.

Final Revisions Should Ease Global Use Of EU GMP Annex I Sterile Drugs Guidance, Associations Say

Final Revisions Should Ease Global Use Of EU GMP Annex I Sterile Drugs Guidance, Associations Say

 
• By Joanne S. Eglovitch

Inter-associations working group suggests changes to the EU GMP Annex I revision to make it easier to understand by health authorities worldwide; the groups point out that the annex will be used globally and not just in Europe.

Kite Exec Highlights Hospital Role In Cell Therapy Quality Chain

Kite Exec Highlights Hospital Role In Cell Therapy Quality Chain

 
• By Joanne S. Eglovitch

Hospitals will have a large role in success of these treatments, with a high level of teamwork and coordination required between the technical operations team and the commercial teams working in tight time-frames.