The Associated Press reports that FDA has been unsuccessful in asserting regulatory control over rapidly proliferating private stem cell clinics.
FDA publishes a revised International Conference on Harmonization guidance on impurities in new drug products.
Federal Register notice: FDA posts a draft guidance entitled Investigator Responsibilities Safety Reporting for Investigational Drugs and Devices.
Federal Register notice: FDA posts a draft guidance entitled Benefit-Risk Assessment for New Drug and Biological Products.
Federal Register notice: FDA makes available a draft guidance entitled Microbiological Quality Considerations in Non-Sterile Drug Manufacturing.
FDA publishes one final and one draft guidance relating to gene therapy products.
FDA clears the Siemens Medical Solutions NAEOTOM Alpha improved CT imaging device, described by the agency as the first major CT technology change in ...
CDER drug safety operations (DSO) associate director Terry Toigo retires and, in the interim, DSO senior staff member Amy Ramanadham has been named ac...