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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
A group of pharmaceutical representatives has recommended 10 product and site quality metrics that the FDA should consider collecting from manufacturers, helping the agency shape its new quality metrics program. Read More
Pfizer subsidiary Meridian Medical Technologies is under continued pressure from the FDA to improve oversight and quality at its Missouri plants. 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
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
Synecco, a China-based contract manufacturer and contract sterilizer, received an FDA warning letter for shortfalls in sterilization validation and other GMP issues. Read More
After falling behind in the race for new diabetes treatments, partners Bristol-Myers Squibb and AstraZeneca Thursday got a boost in the form of a nearly unanimous recommendation from FDA advisors for their drug Forxiga. Read More
As more critics of the FDA’s approval of the painkiller Zohydro ER come forward, the agency says it will not limit approval of new opioid painkillers to those with abuse-deterrent properties. Read More
A new House bill aims to build on the success of the Generating Antibiotics Now (GAIN) Act by allowing drugmakers to submit less data for antibiotics and antifungals that affect limited patient populations. Read More