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Novel Laboratories failed to adequately address black specks on drug products and pieces of rubber found in a product container, according to a Form 483 given to the drugmaker. Read More
Roche subsidiary Genentech received a Form 483 from the FDA after an inspection found parts of the processing area for making active pharmaceutical ingredients (APIs) was covered with what resembled rust. Read More
China’s Food and Drug Administration (CFDA) is renewing its push to have all manufacturers of blood products, vaccines and sterile injectables obtain a revised good manufacturing practices (GMP) certificate. Read More
A newly introduced House bill would legalize the personal importation of prescription drugs nationally, following a Maine law enacted in 2013 that is currently facing a legal challenge brought by the pharmaceutical industry. Read More
The generics industry enters uncharted territory in 2014 as it adjusts to a landscape altered by monumental Supreme Court rulings in 2013 and the FDA’s proposed rule to authorize generic drugmakers, for the first time, to change product labeling in response to safety signals. Here’s an overview of the significant events that happened in 2013 and how they promise to shape the industry in 2014 and beyond. Read More
Merck KGaA’s Mexican subsidiary received a Form 483 for inadequately looking into a glass defect and not examining devices used in its products. 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
Nevada-based Green Valley Drugs, which recalled all of its sterile compounded products in April, has been warned by the FDA for a lack of sterility assurance and general quality control. Read More
Negotiators overseeing a civil suit related to last year’s nationwide outbreak of fungal meningitis say they have reached a tentative settlement with the Massachusetts compounder linked to the outbreak that could see victims and creditors receive more than $100 million. Read More
Alimera Sciences’ negotiations with the FDA on Iluvien have put the diabetic macular edema drug on a glide path to potential approval — a startling about-face following three complete response letters (CRL) for the drug’s application. Read More