FDA posts considerations for applicants to consider when deciding when to submit elemental impurity data to the agency.
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for AstraZenecas Farxiga (dapagliflozin) is 3,...
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Gilead Sciences Genvoya is 5,031 days.
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Scott Laboratories Sedasys System is 2,816...
During a 2/6 address to the Alliance for a Stronger FDA, commissioner Scott Gottlieb discusses new efforts on biosimilar competition, OTC drug product...
A DC federal court has granted Medtronic and Unomedical summary judgment on several courts in complex litigation involving a Medtronic pump and infusi...
FDA says Pentax has recalled duodenoscopes to replace several parts to improve reprocessing effectiveness.
Attorney Michelle Yeary says a New York federal court finally ruled on a Sun Pharmaceutical motion to dismiss claims in a failure to warn suit five ye...