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Last updated 1 day ago

Competitive Generic Therapy Approvals

1 day ago

Explore the FDA’s Competitive Generic Therapy Approvals page, offering insights into the...

IND Application Procedures: Exemptions from IND Requirements

1 day ago

Before submitting an IND application, investigators should refer to the Guidance for...

IND Application Procedures: Investigator's Responsibilities

1 day ago

This page provides the key points that investigators should consider in order...

IND Application Reporting: Overview

1 day ago

IND Application Reporting: Overview

IND Application Procedures: Interactions with FDA

1 day ago

Sponsors of IND applications may obtain advice and guidance from FDA at...

IND Applications for Clinical Investigations: Overview

1 day ago

An overview of terms related to IND Applictions

IND Application Reporting: Protocol Amendments

1 day ago

Once an IND application is in effect, the sponsor of the application...

General Drug Categories

1 day ago

General Drug Categories

Addresses to Send Applications

1 day ago

Addresses to Send Applications

OMUFA Reauthorization: Fiscal Years 2026 - 2030

3 days ago

This page is the main website for information pertaining to OMUFA reauthorization...

Human Drug Compounding Outsourcing Facility Fees

3 days ago

Human Drug Compounding Outsourcing Facility Fees

A Special Year, New Seal, and Renewed Commitment to the American People

4 days ago

The FDA has unveiled an official agency seal which signifies the many...