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Latest posts
Last updated about 13 hours ago
Expedited IND Pilot Program Educational Webinar for Stakeholders - 08/06/2026
about 14 hours ago
An educational webinar on a proposal to establish the Expedited Investigational New...
Cancer Clinical Trial Eligibility Criteria: Performance Status
about 15 hours ago
Guidance for Industry, IRBs, and Clinical Investigators
Cancer Clinical Trial Eligibility Criteria: Laboratory Values
about 15 hours ago
The purposes of eligibility criteria for cancer clinical trials are to select...
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications
about 15 hours ago
The purposes of eligibility criteria for cancer clinical trials are to select...
BK261351- ADAMII CD34 System
4 days ago
ADAMII CD34 System includes ADAMII-CD34 Kit which is designed for use with...
Biologics PREA Reviews and Labeling Changes
4 days ago
PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies...
OTP Town Hall: Best Practices for Regulatory Interactions with OTP - 12/12/2024
5 days ago
CBER/OTP is hosting its next virtual town hall on December 12, 2024...
OTP Town Hall: Cell Therapy CMC Readiness for Late-Stage INDs - 09/05/2024
5 days ago
The focus of this virtual town hall was to answer questions related...
FluMist
5 days ago
For the active immunization of individuals 2-49 years of age against influenza...
FDA Rare Disease Innovation Hub
6 days ago
FDA created the Rare Disease Innovation Hub (the Hub) to serve as...
Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions
8 days ago
Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff...