Allergenics
Allergen Extracts, Allergen Patch Tests, Antigen Skin Test
Blood & Blood Products
Blood, Blood Components, Blood Bank Devices, Blood Donor Screening Tests
Cellular & Gene Therapy Products
Gene-based Treatments, Cell-based Treatments, Cloning
Guidance, Compliance & Regulatory Information
Guidance, Rules, SOPPS, Establishment Registration, Enforcement, Compliance
Tissue & Tissue Products
Bone, Skin, Corneas, Ligaments, Tendons, Stem Cells, Sperm, Heart Valves
Vaccines
Vaccines for Use in Children and Adults, Tuberculin Testing
Xenotransplantation
Transplantation of Non-Human Cells, Tissues or Organs Into a Human
Development & Approval Process
Advertising & Labeling, IND, Expanded Access, PMA, BLA, NDA, 510(k)
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.
What’s New for Biologics
Latest news from the Center for Biologics and Evaluation at FDA.
Follow CBER on Twitter
CBER’s main goal for Twitter is to provide up-to-date information to consumers, health professionals, regulated industry and other interested stakeholders about CBER regulated products.
Workshops, Meetings & Conferences
FDA’s Center for Biologics Evaluation and Research (CBER) sponsors or co-sponsors meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.