Allergen Extracts, Allergen Patch Tests, Antigen Skin Test
CBER’s Document Control Center (DCC) will not process any submissions received by mail or courier including submissions provided on paper and electronic media (e.g., CDs, USB drives) until further notice. Submissions may be sent through the Electronic Submission Gateway or in some cases by e-mail. Please see the Letter to CBER Sponsors, Applicants and Regulated Entities.
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry
COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry
Impact of Severe Weather Conditions on Biological Products
CBER is providing interested persons with information concerning the storage and use of temperature-sensitive biological products that have been involved in a temporary electrical power failure or flood conditions.Learn more...
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
White Oak Campus
10903 New Hampshire Ave
Silver Spring, MD 20993