Four FDA senior officials explain how the agency is strengthening its good clinical practice oversight in an increasingly globalized clinical trial en...
FDA publishes a request for information on stakeholders views on ways to accelerate botanical drug development.
The Senate Special Committee on Aging chairman and ranking member ask the Government Accountability Office to study and assess any connection between ...
FDA warns Indias Shoolin Pharma Chem that it is producing active pharmaceutical ingredients in insanitary conditions and with significant CGMP deviati...
FDA orders a Boxed Warning for American Regents Injectafer (ferric carboxymaltose injection) over the risk of symptomatic hypophosphatemia.
Following a course reversal by FDA, uniQure files a BLA seeking accelerated approval of ifezuntirgene inilparvovec (AMT-130), an investigational gene ...
CDRH issues an alert on AVID Medical convenience kits based on a letter the company sent to customers recommending that certain kits be corrected prio...
A Friends of Cancer Research white paper recommends a new approach to support administered activity escalation and dosage optimization in developing r...
