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Teva is voluntarily recalling 19,504 bottles of amphetamine tablets that could contain impurities, the latest in a series of recalls by the company this year. Read More
A Luxembourg-based nonprofit set up by European pharma groups is one step closer to launching a counterfeit drug repository system, having finalized contracts with three software firms to help implement the system. Read More
A recent survey showing that drug company executives are often unaware of problems faced by their quality control units may point to an overlooked contributing factor in FDA warning letters, an expert says. Read More
The European Medicines Agency issued draft guidance last month on the manufacture of finished dosage forms, clarifying the information drugmakers should include in the quality section of the common technical document in a premarket application. Read More
The U.S. Food and Drug Administration has identified 10 quality data points that finished dosage form and active pharmaceutical ingredient makers will need to collect to calculate four quality metrics for each product they produce. Read More
A House Energy and Commerce Committee report on cybersecurity breaches at HHS blames the FDA for not acting forcefully enough to prevent a known web vulnerability that has been a security concern for the past decade. Read More
IPEC-Americas is urging excipient makers to follow its voluntary guideline on stability testing in the wake of recent requests by foreign regulators for stability data. Read More
Genzyme received a 16-observation Form 483 from the FDA for not conducting risk assessments and other quality lapses at a facility where bulk drug substances are made. Read More