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FDA Continues to Referee the CBD Market

Producers of CBD products must also appraise their quality-control procedures to ensure safe products are hitting the market.As we forecasted last December at a past legal alert, the U.S. Food and Drug Administration continues...

FDA Reissues Notice Announcing Enriched OTC Monograph Facility Charges

On March 26, 2021, the FDA updated and reissued the charge rates for the recently created over-the-counter (OTC) monograph Drug User Fee application (OMFUA) to get FY2021 at a Federal Register Notice (FRN) titled"Fee...
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FDA Center for Clinical Trial Innovation: Improving Trial Processes and Patient Safety

In April 2024, the U.S. Food and Drug Administration Center for Drug Evaluation and Research (CDER) introduced the Center for Clinical Trial Innovation (C3TI) to enhance communication and collaboration in clinical trials. C3TI aims...