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The FDA late Friday approved Cubist Pharmaceuticals’ antibiotic Zerbaxa to treat complicated intra-abdominal infections and urinary tract infections, the latest approval granted through an initiative to encourage antibiotic development. Read More
Drug and device manufacturers would have to submit all clinical trial data to the federal government — including data for products never approved by the FDA — under a massive, proposed expansion of data collection. Read More
German regulators have published a list of 80 generic medicines whose approvals were yanked after EU authorities expressed concerns with contract research organization GVK Biosciences. Read More
Pfizer’s blockbuster arthritis pain drug Celebrex is facing generic competition for the first time after Teva, Mylan and Actavis launched versions Wednesday. Read More
European regulators have approved AstraZeneca and Nektar Therapeutics’ opioid-induced constipation drug Moventig for adults that have not responded to laxatives. Read More
Lax procedural documentation in quality control units topped the list of reasons why drugmakers received Form 483s in fiscal 2014, its ninth consecutive year at the top, while poor laboratory controls jumped to second place from fourth in the annual rankings of inspection observations. Read More
The FDA slapped Mani Hanoi, a Vietnam maker of surgical sutures with attached needles, with a warning letter for particle monitoring slips and other GMP issues. Read More
The FDA is requiring drugmakers to revamp their product labeling to include clearer information on the safe use of drugs and biologicals in pregnant women and nursing mothers, marking the first labeling requirement of its kind since the late 1970s. Read More
The FDA is expected to start training investigators next year on how to tell whether a facility’s quality culture is good or poor, a development that lays the groundwork for eventual scrutiny of this new indicator during inspections. Read More
With 1,250 drug master files submitted for completeness assessment (CA) review since GDUFA’s Oct. 1, 2012 implementation date, the FDA’s Office of Generic Drugs has hired additional staff and prioritized the review of DMFs using a risk-based tiered approach. Read More