Federal Register notice: FDA makes available a draft guidance entitled Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry.
FDA releases three new and three updated guidances to help sponsors developed gene therapy products, including for specific diseases.
Federal Register notice: FDA seeks comments on an information collection extension for its Guidance on Formal Meetings With Sponsors and Applicants fo...
Federal Register notice: FDA makes available a draft guidance entitled Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Preventio...
CDERs Office of Prescription Drug Promotion says an Arog exhibit booth and Web page are promoting its investigational unapproved new drug Crenolanib.
FDA approves a Medtronic PMA for a less-invasive implant approach for its HVAD System, a left ventricular assist device for patients with advanced hea...
The Justice Department establishes a Task Force on Market Integrity and Consumer Fraud to step up efforts against healthcare and other types of fraud.
FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), an anti-PD-1 therapy for treating previously treated patients w...