CBER publishes a Standard Operating Policy and Procedure resource on complying with provisions of the Pediatric Research Equity Act and the Best Pharm...
Four stakeholders recommend ways FDA can improve a draft guidance on leveraging prior knowledge in developing some human gene therapy products.
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...
FDA warns Fresenius Medical Care North America about CGMP violations at its Ogden, UT, drug manufacturing facility.
