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An HHS watchdog will audit how the FDA inspects generics manufacturing facilities, oversees postmarketing studies and ensures compliance with clinical trial reporting requirements, as well as how the drug industry is implementing the track-and-trace law. Read More
Starting early next year, manufacturers will learn faster whether their drug applications have serious quality deficiencies under a sweeping reorganization of CDER’s quality functions into a new “super office.” Read More
Citing quality problems at two of Ranbaxy’s Indian manufacturing facilities, the FDA has revoked its tentative approvals for two of the company’s ANDAs, one for a generic of AstraZeneca blockbuster Nexium and the other for Hoffman-LaRoche AIDS drug Valycte. Read More
Agila Specialties failed to conduct complete investigations into customer complaints, forcing the FDA to give the Indian manufacturer with a Form 483. Read More
The FDA has warned two Florida-based compounders, one for repeatedly making drugs without a prescription and another for more than 30 adverse events connected to its products. Read More
The FDA will require large compounding pharmacies to register each year, pay a $15,000 annual fee and report a detailed list of all the products they manufacture every six months. Read More
Europe’s drug regulatory agency has revised the conflict of interest policy for its scientific committee members and experts, a move that one attorney says recognizes the reality that most knowledgeable specialists have at least some commercial involvement. Read More
An advisory panel of the European Medicines Agency last week recommended approval of two AbbVie drugs for hepatitis C, a Genzyme drug for type 1 Gaucher disease, and a change in classification of HRA Pharma’s emergency contraceptive. Read More
The British government is looking to speed new drugs to market and provide faster patient access to medicines, an initiative that some industry experts say should include reforms of the UK’s healthcare reimbursement body. Read More
Generic versions of the Hoffman-La Roche AIDS drug Valcyte can move forward after a federal judge denied Ranbaxy’s request for a restraining order on alternate versions of the therapy, as well as AstraZeneca’s blockbuster heartburn drug Nexium. Read More
India’s drug pricing authority is proposing a requirement to display special markings and ceiling prices on labels for life-saving and essential drugs, an idea that one observer says should have included input from the country’s drug regulator. Read More