Drugs@FDA Data Files
Fri Jun 12 10:00 am
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
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FDA | What's New: Vaccines
Meeting 2: Patient and Care Partner Perspectives on Early Enrollment into Gene Therapy Clinical Trials for Rare Diseases
Thu Jun 11 2:02 pm
Gene therapy trials inform risks & benefits for informed decisions. Long-term follow-up crucial for safety & durability assessment.
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Allergenics Research
Thu Jun 11 2:01 pm
List of Immunobiochemistry and Biologics Science & Research for Consumers - Allergenics Research
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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
Thu Jun 11 1:58 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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Coronavirus (COVID-19) | CBER-Regulated Biologics
Thu Jun 11 1:50 pm
This page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance.
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What’s New for Biologics
Wed Jun 10 4:29 pm
Public Webinar: FDA Review of Biologics License Applications for Blood and Source Plasma - 05/12/2026
Wed Jun 10 4:20 pm
This webinar is intended to provide blood establishments and other stakeholders with an overview of OBRR’s approach to the review of biologics license applications for the manufacture of blood and blood components, including source plasma. In this event, OBRR staff will give presentations on select topics and address questions submitted by registra
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ELEVIDYS
Wed Jun 10 2:33 pm
Treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.
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NUVAXOVID
Wed Jun 10 1:43 pm
NUVAXOVID 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).
NUVAXOVID 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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NUVAXOVID 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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Cleared 510(k) Submissions with Supporting Documents - 2026
Wed Jun 10 12:40 pm
510(k) Blood Establishment Computer Software - 2026
Wed Jun 10 12:39 pm
BK261333- Blood Product Questionnaire Module (v2.0.0)
Wed Jun 10 12:34 pm
The Blood Product Questionnaire Module supports single and/or multi-site blood establishment collection facilities’ creation of a donor history questionnaire, the collection of donor history, the determination of visit requirements, the determination of donor eligibility, and unit suitability.
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