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Latest posts
Last updated about 19 hours ago
FDA Grand Rounds – Anti-biofilm Technologies for Enhancing the Safety of Medical Device Surfaces - 05/29/2025
about 20 hours ago
Anti-biofilm Technologies for Enhancing the Safety of Medical Device Surfaces, May 29...
CDER Small Business and Industry Assistance (SBIA) Learn
4 days ago
SBIA Learn offers a variety of multimedia resources to provide information that...
Registered Outsourcing Facilities
4 days ago
Discover FDA's comprehensive list of registered outsourcing facilities engaged in human drug...
Search for Regulatory References | Drugs
5 days ago
Find information on drug development, applications, submissions, manufacturing & quality, safety, labeling...
Safety labeling update for capecitabine and fluorouracil (5-FU) on risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency
5 days ago
The U.S. Food and Drug Administration (FDA) is providing this communication to...
INFORMED CONSENT TEMPLATE FOR INDIVIDUAL PATIENT EXPANDED ACCESS
5 days ago
INFORMED CONSENT TEMPLATE FOR INDIVIDUAL PATIENT EXPANDED ACCESS
Antibacterial Susceptibility Test Interpretive Criteria
5 days ago
Antibacterial Susceptibility Test Interpretive Criteria
E22 General Considerations for Patient Preference Studies
5 days ago
E22 General Considerations for Patient Preference Studies
Rare Disease News, Events & Reports
5 days ago
Learn more about recent news and events related to rare diseases and...
Rare Disease Drug Approvals
5 days ago
This page describes recent rare disease drug approvals that received a CDER...
Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D)
5 days ago
As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare...