CBER director Peter Marks says he wants to continue the Operation Warp Speed attention and quick approval process given to Covid-19 vaccines after the...
FDA approves an oral suspension formulation of Mitsubishi Tanabe Pharma Americas Radicava (edaravone) for treating adults with amyotrophic lateral scl...
The Government Accountability Office says FDA should develop a policy on starting and ending enforcement discretion for unauthorized tests in future p...
Aurobindo reports receiving a six-item FDA 483 after an inspection at its Unit VII oral drug manufacturing unit in Jadcherla, Hyderabad, India.
CDER medical office Joseph Rajendran explains FDAs role in developing technology to produce medical isotopes without using highly enriched uranium.
FDA provides an overview of its new Enterprise Modernization Action Plan effort.
FDA extends for 90 days the PDUFA review action dates for Amicus BLA and NDA for components of its AT-GAA, intended to treat late-onset Pompe disease....
Ropes & Gray attorneys see increasing cybersecurity expectations for medical device manufacturers in FDA regulations and congressional legislation.