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The FDA is continuing its nationwide effort to single out compounding facilities that don’t conform to GMP regulations, and it blasted two pharmacies in Florida in recent warning letters. Read More
A nonprofit coalition is calling for congressional action that would allow the FDA to offer formal scientific opinions on the use of medical products outside the U.S. to streamline and strengthen regulatory pathways for drugs and vaccines in less developed countries. Read More
Citing a national opioid crisis and the frequency of deaths associated with OxyContin overdoses, a lawmaker is asking FDA Commissioner Robert Califf about how the agency administers Risk Evaluation and Mitigation Strategies for prescription opioids. Read More
An FDA inspection uncovered a host of GMP deficiencies at a Wockhardt production plant in India, despite earlier attempts by the company to downplay the findings. Read More
It’s been a tough road for Duchenne candidates this year, with one getting rejected outright and another facing an unsympathetic advisory committee panel next Monday. Read More
The FDA has hit Oeyama-Moto Cancer Research Foundation’s IRB for failing to define its operational protocol, leading to inadequate communication with clinical investigators and meager documentation. Read More
GlaxoSmithKline is appealing a $54 million fine from the UK’s Competitions and Market Authority over pay-for-delay allegations, contending the company’s conduct was “objectively justified.” Read More