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NASA’s Advancements in Space Continue Generating Products on EarthThe latest edition of NASA’s Spinoff publication, which highlights the successful transfer of agency technology to the commercial sector, is now available online. For nearly…
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FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and ManufacturingAI/ML can help bring safe, effective, and high-quality treatments to patients faster. This post highlights the discussion papers, “Using Artificial Intelligence and Machine Learning in the Development of Drug…
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Lessons Learned from COVID-19 Are Informing Preparation for Future Public Health Emergencies
While the HHS public health emergency is ending, COVID-19 remains a high priority and the U.S. Food and Drug Administration will remain engaged with numerous activities to protect and promote public health.
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What to Know About Breast Implants
The U.S. Food and Drug Administration regulates breast implants as medical devices. Get the latest information to help you make an informed decision about whether…
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What’s New for Biologics
Latest news from the Center for Biologics Evaluation and Research
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FDA’s IT Strategy: Unlocking Potential, Leading Transformation
FDA has released its comprehensive FDA Information Technology Strategy for Fiscal Years 2024 to 2027 (IT Strategy), marking a defining roadmap for the agency’s technological advancement and the alignment with…
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Thoughts on Singapore, and FDA’s Ongoing Work to Improve Public Health
Our trip to Singapore offered us an opportunity to think about the FDA’s global presence, strengthen ties with an FDA strategic partner, and discuss opportunities and challenges in applying technological…
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VAERS: A Critical Part of the National Vaccine Safety System
Monitoring vaccine safety is an important responsibility shared by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA).
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Increasing Options in Clinical Research to Facilitate Medical Product Development
FDA issued a final rule to help advance medical product development without compromising the rights, safety and welfare of people participating in clinical research.
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Realizing the Promise of Real-World Evidence
Realizing the full potential of RWE in regulatory decision-making presents several challenges, and work is underway at the FDA to better understand this area.
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