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The FDA and EMA will expand their joint inspection activities to include facilities involved with bioequivalence studies for generic drug applications. Read More
In a new enforcement initiative intended to boost drugmaker quality, the European Medicines Agency (EMA) has begun publishing the names of manufacturing facilities that fall out of compliance with good manufacturing practices (GMP). Read More
To satisfy new Australian guidance on supplier qualification for raw materials, drugmakers need to stop using one-size-fits-all questionnaires and adopt screening methods that are specific to the products they are making. Read More
Drugmakers are pushing back on proposed EU GMP requirements that would expand safeguards against product cross-contamination, saying the proposed six-month timeline for implementation is unworkable. Read More
Generics makers should design tablets and capsules to be similar in size and shape to their reference listed drug (RLD) when they seek ANDA approval, the FDA says. Read More
The European Medicines Agency has concluded a review of lax adverse event reporting at Roche, concluding the company’s failure last year to report adverse events for 19 drugs did not cause any additional risks to consumers. Read More
OTC drugmaker AmeriDerm Laboratories has a long history of failing to test its Paterson, N.J., plant’s water supply for objectionable microorganisms, the FDA says. Read More
The FDA has handed Jubilant HollisterStier a warning letter for quality shortcomings at its Spokane, Wash., sterile drug manufacturing facility. Read More
The FDA issued a Form 483 to Biogen Idec that cites a weakness in the way the company manages suppliers, highlighting the difficulties drugmakers continue to have with supplier quality issues. Read More
HHS has approved the overhaul of the FDA's Office of Generic Drugs (OGD), allowing the agency to move most of its functions relating to generic drugs under one roof. Read More
The FDA may refine its planned quality metrics program to include rankings of individual drugmaker quality — at the request of industry — that will show how a company’s quality system stacks up against its peers. Read More