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Latest posts
Last updated about 19 hours ago
CDER Small Business and Industry Assistance (SBIA) Learn
about 19 hours ago
SBIA Learn offers a variety of multimedia resources to provide information that...
Registered Outsourcing Facilities
about 23 hours ago
Discover FDA's comprehensive list of registered outsourcing facilities engaged in human drug...
Search for Regulatory References | Drugs
1 day 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
1 day ago
The U.S. Food and Drug Administration (FDA) is providing this communication to...
INFORMED CONSENT TEMPLATE FOR INDIVIDUAL PATIENT EXPANDED ACCESS
1 day ago
INFORMED CONSENT TEMPLATE FOR INDIVIDUAL PATIENT EXPANDED ACCESS
Antibacterial Susceptibility Test Interpretive Criteria
2 days ago
Antibacterial Susceptibility Test Interpretive Criteria
E22 General Considerations for Patient Preference Studies
2 days ago
E22 General Considerations for Patient Preference Studies
Rare Disease News, Events & Reports
2 days ago
Learn more about recent news and events related to rare diseases and...
Rare Disease Drug Approvals
2 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)
2 days ago
As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare...
Rare Diseases Team
2 days ago
The Rare Diseases Program facilitates, supports and accelerates the development of drug...