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The HHS Office of Inspector General (OIG) this year plans to analyze the findings from FDA inspections of generic drugmakers’ facilities to determine the effectiveness of inspections on ensuring the quality of generic medicines. Read More
PhRMA placed itself in the middle of a mounting battle over biosimilar naming Monday, calling on the FDA to deny GPhA’s petition for same-name biosimilars and arguing that distinguishable, yet related names are “essential” for adverse event reporting. Read More
CDER plans to issue highly anticipated guidance in 2014 that addresses social media usage for pharma marketing and the specifics about its biosimilars approval pathway. Read More
Beginning in June, drugmakers selling in the EU must notify the European Medicines Agency (EMA) of any unreported changes or updates to product marketing authorizations in any member states and must complete that update on all products by December. Read More
The compounding pharmacy lobby is pushing back against the FDA’s campaign to encourage hospitals to buy compounded drugs only from agency-registered sites as disingenuous and misleading, saying the products aren’t necessarily safer for patients. Read More
Quebec drugmaker Valeant Pharmaceuticals is acquiring Rhode Island’s PreCision Dermatology in a transaction expected to close in the first half of this year. 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
Proposed international guidelines on metal impurities in finished drugs may be impossible to meet because they lack specificity and are impractical for suppliers, drugmakers say. Read More
Japan’s national drug regulator has asked drugmakers to submit information on stability monitoring and water purity, in addition to existing requirements, when they apply for mandatory post-approval GMP inspections. Read More
Pharma companies applying for approval to sell drugs in Canada must submit quality summary documents, certifications of their products’ comparability with monographs of the European Pharmacopoeia and detailed drug master files that comply with the International Conference on Harmonisation’s (ICH) registration for human use quality standards. Read More