Today, the U.S. Food and Drug Administration issued a Request for Information (RFI) regarding labeling and preventing cross-contact of gluten in packaged food.
Category: Regulatory
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FDA ImportShield Program Delivers Impressive Results in Strengthening FDA Oversight at U.S. Ports of Entry
The U.S. Food and Drug Administration today announced its initial review of the effectiveness of the FDA ImportShield Program (FISP), which launched in August 2025 to modernize how the FDA reviews imported products.
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FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation
The U.S. Food and Drug Administration today announced it is sharing information about the agency’s flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGT).
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FDA Issues Guidance on Modernizing Statistical Methods for Clinical Trials
The U.S. Food and Drug Administration today published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping drug developers make better use of available data, conduct more efficient clinical trials, and deliver safe and effective t
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FDA Approves First Treatment for Children With Menkes Disease
The U.S. Food and Drug Administration today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients.