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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
Sponsors with pending NDAs and ANDAs backed by trials conducted at India’s Semler Research Limited must return to the drawing board because of data integrity issues, the FDA said. Read More
The National Institutes of Health has suspended production at two of its facilities following an investigation last year that found a National Cancer Institute laboratory conducting cell therapy production and a National Institute of Mental Health facility producing positron emission tomography materials, were not GMP-compliant. Read More