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Last updated 2 days ago
Competitive Generic Therapy Approvals
2 days ago
Explore the FDA’s Competitive Generic Therapy Approvals page, offering insights into the...
IND Application Procedures: Exemptions from IND Requirements
2 days ago
Before submitting an IND application, investigators should refer to the Guidance for...
IND Application Procedures: Investigator's Responsibilities
2 days ago
This page provides the key points that investigators should consider in order...
IND Application Procedures: Interactions with FDA
2 days ago
Sponsors of IND applications may obtain advice and guidance from FDA at...
IND Applications for Clinical Investigations: Overview
2 days ago
An overview of terms related to IND Applictions
IND Application Reporting: Protocol Amendments
2 days ago
Once an IND application is in effect, the sponsor of the application...
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...