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FDA’s ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital health technology for neuroscience

FDA’s Center for Drug Evaluation and Research (CDER) recently accepted a new submission into the Innovative Science and Technology Approaches…

Resources for Biomarker Requestors

Information and resources for requestors about FDA’s Biomarker Qualification Program

Clinical Outcome Assessments (COA) Qualification Program Resources

Resources and information for requestors interested in CDER’s Clinical Outcome Assessments (COA) Qualification Program. This update contains the Letter of…

Clinical Outcome Assessments (COA) Qualification Program Submissions

Clinical Outcome Assessments (COA) Qualification Program Submissions

Qualified Clinical Outcome Assessments (COA)

The table below lists qualified Clinical Outcome Assessments (COA). The tables include legacy projects (those submitted prior to passage of…

www.24hreup.biz – 700358 – 04/23/2025

Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet

www.bigpharmausa.com – 702681 – 06/04/2025

Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet

www.buycodeine.us – 702527 – 05/05/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

www.buyprosoma.com – 705973 – 06/10/2025

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

Zhejiang Huahai Pharmaceutical Co., Ltd. – 707145 – 06/06/2025

CGMP/Finished Pharmaceuticals/Adulterated