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November 6, 2024

Research Tools and Resources

The tools and resources that are currently available for drug developers are listed below. Please check back for updates. Databases DDTs allow us to work with […]
November 6, 2024

Search for Regulatory References | Drugs

Search for Pharmaceutical Quality Documents Pharmaceutical Quality and Manufacturing Multiple Endpoints Guidance Snapshot Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Ethical Considerations for Clinical […]
November 5, 2024

FDA Roundup: November 5, 2024

For Immediate Release: November 05, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]
November 5, 2024

Post-Warning Letter Meetings Under GDUFA

Docket Number: FDA-2023-D-3370 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides information on the implementation of the Post-Warning Letter Meeting process […]
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