Search Results: FDA

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Form FDA 483 Response Best Practices Announced by the FDA

In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency provides some wisdom on best practices for responding to Form FDA 483s, albeit in the context of its Bioresearch Monitoring (BIMO) program…

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Designating a Platform Technology: FDA’s Long-Awaited Draft Guidance

In newly released Draft Guidance from the U.S. Food and Drug Administration (FDA) entitled, Platform Technology Designation Program for Drug Development, the FDA addresses its new designation program for platform technologies, which is intended to bring efficiencies to drug development, manufacturing, and review processes for applications that incorporate designated platform technologies. Read the…

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Master(ing) Protocols for Randomized Umbrella and Platform Trials

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency previously set forth in guidance for COVID-19 master protocols (2019), master protocols in oncology (2022) and clinical trials for multiple versions…

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How to Get Your SIUU Out: FDA Provides Long-Awaited Update for Industry on Communicating Off-Label Information

On October 23, 2023, FDA announced the availability of a revised draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” The draft guidance supersedes the agency’s 2014 draft guidance, “Distributing Scientific and Medical Publications on Unapproved New Uses,” and…

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Recent FDA Initiatives to Support Development of Individualized Cell and Gene Therapies and Rare Disease Therapies

Last month, FDA issued a Request for Information (RFI) in the Federal Register seeking information and comments from interested stakeholders regarding “critical scientific challenges and opportunities to advance the development of individualized cellular and gene therapies (CGTs).” Individualized CGTs are therapies “developed for a single patient (or a very small…

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FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part II: FDA’s Proposed Phaseout Policy – Key Considerations & Open Questions

hands and test tube

After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs. If finalized as proposed, FDA would implement a new “phaseout policy” that would, across five stages and within four years, apply the same regulatory requirements applicable to in…

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FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part I: Underpinnings of FDA’s Proposed Rule

On October 3, 2023, the U.S. Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). The proposed rule and policy are the latest in an over decade-long discourse amongst interested stakeholders – laboratories, IVD manufacturers, regulatory agencies, Congress, providers, and patients –…

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FDA Proposes Phased Approach to Regulating Laboratory Developed Tests

On September 29, 2023, the U.S. Food and Drug Administration (FDA) posted and scheduled for publication its long-awaited proposed rule concerning FDA regulation of laboratory developed tests (LDTs).  If enacted, the proposed rule would amend the Agency’s regulations to make explicit that in vitro diagnostic products (IVDs) are devices under…

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