FDA and representatives of the generic drug industry meet bi-annually to discuss current and emerging regulatory science challenges and concerns. Minutes from these meetings are posted […]

On This Page Date: December 12, 2024 Time: 12:30 PM – 5:00 PM ET FDA announces public workshop on optimizing use of real-world evidence – looking […]

Image Avoid using imported medicines, especially for children. Medications from other countries might not have been evaluated for safety and effectiveness. These products may be addictive […]

There are a number of OTC drugs that can be used to treat nasal congestion symptoms related to colds or allergies. Other OTC drugs that can […]

Summary Company Announcement Date: November 04, 2024 FDA Publish Date: November 05, 2024 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and […]

Summary Company Announcement Date: November 04, 2024 FDA Publish Date: November 06, 2024 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and […]

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 […]

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 […]

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 […]