A final FDA guidance urges sponsors of cancer clinical trials to broaden laboratory value-based eligibility criteria to reduce unnecessary barriers to...
FDA announces an 8/6 educational Webinar to provide stakeholders with additional information about its proposed Expedited Investigational New Drug Pil...
An FDA advisory committee 7/23 voted to recommend allowing several controversial peptides to be considered for inclusion on the agency's Section 503A ...
Amgen files new scientific data and analyses in its bid to prevent FDA withdrawal of Tavneos (avacopan), arguing that the treatment continues to demon...
FDA issues a Complete Response Letter to Apiject Systems Corp., declining to approve the company's NDA for a glycopyrrolate solution drug-device combi...
FDA issues an early alert warning about a potentially high-risk issue involving certain lots of Boston Scientific's ENROUTE Transcarotid Neuroprotecti...
FDA cites Bausch + Lomb for GMP deficiencies following a 3/12-20 inspection of the company's sterile drug manufacturing facility in Tampa, FL.
FDA publishes a strategy document on facilitating chemistry, manufacturing, and controls readiness for products in accelerated development, completing...
