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Last updated 2 days ago

CDER Small Business and Industry Assistance (SBIA) Learn

2 days ago

SBIA Learn offers a variety of multimedia resources to provide information that...

Registered Outsourcing Facilities

2 days ago

Discover FDA's comprehensive list of registered outsourcing facilities engaged in human drug...

Search for Regulatory References | Drugs

3 days ago

Find information on drug development, applications, submissions, manufacturing & quality, safety, labeling...

INFORMED CONSENT TEMPLATE FOR INDIVIDUAL PATIENT EXPANDED ACCESS

3 days ago

INFORMED CONSENT TEMPLATE FOR INDIVIDUAL PATIENT EXPANDED ACCESS

Cefiderocol Injection

3 days ago

Cefiderocol Injection - FDA Identified Interpretive Criteria

Antibacterial Susceptibility Test Interpretive Criteria

3 days ago

Antibacterial Susceptibility Test Interpretive Criteria

E22 General Considerations for Patient Preference Studies

3 days ago

E22 General Considerations for Patient Preference Studies

Rare Disease News, Events & Reports

3 days ago

Learn more about recent news and events related to rare diseases and...

Rare Disease Drug Approvals

3 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)

3 days ago

As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare...

Rare Diseases Team

3 days ago

The Rare Diseases Program facilitates, supports and accelerates the development of drug...