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Latest posts
Last updated about 11 hours ago
Search for Regulatory References | Drugs
about 11 hours 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
about 15 hours ago
The U.S. Food and Drug Administration (FDA) is providing this communication to...
INFORMED CONSENT TEMPLATE FOR INDIVIDUAL PATIENT EXPANDED ACCESS
about 17 hours ago
INFORMED CONSENT TEMPLATE FOR INDIVIDUAL PATIENT EXPANDED ACCESS
Cefiderocol Injection
about 18 hours ago
Cefiderocol Injection - FDA Identified Interpretive Criteria
Antibacterial Susceptibility Test Interpretive Criteria
about 18 hours ago
Antibacterial Susceptibility Test Interpretive Criteria
E22 General Considerations for Patient Preference Studies
about 18 hours ago
E22 General Considerations for Patient Preference Studies
Rare Disease News, Events & Reports
about 19 hours ago
Learn more about recent news and events related to rare diseases and...
Rare Disease Drug Approvals
about 19 hours 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)
about 19 hours ago
As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare...
Rare Diseases Team
about 19 hours ago
The Rare Diseases Program facilitates, supports and accelerates the development of drug...
Office of Infectious Diseases Research Activities
about 19 hours ago
Overview of research needs, requests for information (RFIs), public workshops/meetings, opportunities for...
Drugs@FDA Data Files
about 20 hours ago
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship...