Allergenics
Allergen Extracts, Allergen Patch Tests, Antigen Skin Test
Vaccines, Blood & Biologics
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SPOTLIGHT
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.
Center
Recently Published Guidances
Recently published Biologics-related Guidances
Sep 15
Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry
Sep 15
Recognition and Withdrawal of Voluntary Consensus Standards
Sep 14
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment
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Center
CBER Press Announcements
Biologics related Press Announcements
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.
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Contact Us
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
(800) 835-4709
(240) 402-8010
Hours Available
Food and Drug Administration
Food and Drug Administration
White Oak Campus
White Oak Campus
10903 New Hampshire Ave
Silver Spring, MD 20993
United States