What’s New for Biologics
Fri Aug 28 5:57 pm
FDA | What's New: Vaccines
Biologics Procedures (SOPPs)
Fri Aug 28 5:26 pm
These Standard Operating Procedures and Policies (SOPPs) are used by staff in FDA's Center for Biologics Research and Review (CBER) in the performance of their duties. They are made available here to the public because CBER is committed to being as transparent as possible in how it operates.
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MFLUSIVA
Fri Aug 28 5:06 pm
MFLUSIVA is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B
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Regulatory Education for Industry (REdI) Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products - 05/19/2026
Fri Aug 28 2:56 pm
Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics.
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FDA Roundtable: Strengthening the Supply Chain for Blood Manufacturing - 09/29/2026
Fri Aug 28 2:53 pm
On September 29, 2026, the Food and Drug Administration’s, Center for Biologics Evaluation and Research, Office of Blood Research and Review is hosting a roundtable on strengthening the supply chain for the collection and manufacturing of Whole Blood and blood components for transfusion and further manufacturing, including Source Plasma.
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Workshops, Meetings & Conferences (Biologics)
Fri Aug 28 2:22 pm
Information on CBER sponsored or co-sponsored meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.
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News & Events (Biologics)
Fri Aug 28 12:13 pm
MNEXSPIKE
Fri Aug 28 12:10 pm
MNEXSPIKE is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). MNEXSPIKE is approved for use in individuals who are:
65 years of age and older, or
12 years through 64 years of age with
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65 years of age and older, or
12 years through 64 years of age with
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Meeting 1: Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases - 09/20/2024
Fri Aug 28 12:09 pm
FDA CBER Patient Listening Meeting: Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases
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Office of Therapeutic Products (OTP) Events, Meetings, and Workshops
Fri Aug 28 11:41 am
Meeting 2: Patient and Care Partner Perspectives on Early Enrollment into Gene Therapy Clinical Trials for Rare Diseases
Fri Aug 28 11:37 am
Gene therapy trials inform risks & benefits for informed decisions. Long-term follow-up crucial for safety & durability assessment.
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COMIRNATY
Fri Aug 28 10:55 am
COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID 19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
COMIRNATY is approved for use in individuals who are:
65 years of age and older, or
5 years through 64 years of age with
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COMIRNATY is approved for use in individuals who are:
65 years of age and older, or
5 years through 64 years of age with
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