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Manufacturing

Set Alert for Manufacturing

Enforcing A Belated Chemistry Lesson – The Nitrosamines In Sartans Saga

How authorities plan to root out the carcinogenic impurities and what it means for other classes of medicines.

Manufacturing Quality Enforcement
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Performance-Based Conditions Could Ease Post-Approval Changes For Process Analytical Technologies, Experts Say

Pharmaceutical industry officials are promoting the idea of “marrying” the concepts of performance-based approaches and process analytical technology in the draft ICH Q12 guideline. Embedding this idea in ICH Q12 would give industry more flexibility in managing post-approval changes and aligns with the guideline’s concept of lifecycle improvement.

Manufacturing Quality United States

Latest From Manufacturing

FDA And EMA Evaluate Claims As Nitrosamine Worries Turn To Zantac

Pharmacy petitions for recalls after finding ‘inherent instability’ in antacid that could pose carcinogenic risk.

Manufacturing Quality

The US FDA Acts To Bolster Adverse Event Reporting For Compounded Drugs

After discovering one firm suppressed over 4,000 compounded-hormone adverse event reports, agency leans on compounders and outsourcers to improve reporting.

Manufacturing Quality

GS1 Standard Would Speed The Sale Of Returned Drugs After November Deadline

New messaging standard from GS1 would enable industry to sell most returned drugs after November DSCSA deadline without running afoul of the FDA.

Distribution Manufacturing

The FDA Proposes Adding Five Of 31 Drug Substances To 503A Bulks List

FDA proposal would allow traditional compounding from five drug substances based on medical need, but not from another 26.

 

Manufacturing Quality

NIIMBL Seeks Advanced Biopharma Manufacturing Proposals To Fund

The public-private partnership has $5.5m for grants to develop continuous manufacturing methods, cell/gene therapy platforms and other biopharmaceutical manufacturing innovations.

United States Manufacturing

Nine More FDA Bulk Compounding Denials Proposed Post-Vasopressin

Expected flurry of FDA proposals against 503B compounding from bulk drug substances follows vasopressin court ruling.

Manufacturing Market Access
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