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...
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Four stakeholders recommend ways FDA can improve a draft guidance on leveraging prior knowledge in developing some human gene therapy products.
FDA releases a draft guidance entitled Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage.
FDA warns Indias Reliance Life Sciences about significant CGMP violations in its production of finished drugs.
