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Pharmaceutical Industry › Medical Research › Draft Guidance

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more

BakerHostetler

FDA Issues Draft Guidance on Diversity Action Plans

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On June 26, 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance setting forth detailed requirements for the submission of Diversity Action Plans (DAPs) by sponsors of certain clinical studies involving...more

Foley & Lardner LLP

Key Takeaways from the FDA’s First Draft Guidance on Clinical Trials with Psychedelic Drugs

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On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights...more

Gardner Law

FDA Publishes First Draft Guidance for Clinical Trials with Psychedelic Drugs

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Lastly, there are several clinical factors the Agency encourages sponsors to consider. One way psychedelics differ from other drugs is that the use of a traditional placebo as a control may be challenging, as an active drug...more

Goodwin

The ABCs of DCTs: New FDA Guidance Provides Recommendations for the Conduct of Decentralized Clinical Trials

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On May 2, 2023, the U.S. Food and Drug Administration (“FDA”) published draft guidance titled “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” (the “Draft Guidance”). ...more

McDermott Will & Emery

FDA Issues Draft Guidance on the Use and Curation of Real-World Data in Registries

McDermott Will & Emery on

The US Food and Drug Administration has issued draft guidance outlining the agency’s recommendations for using real-world data from (and curating such data in) registries to support regulatory decision-making. Pharmaceutical...more

Faegre Drinker Biddle & Reath LLP

FDA Issues Draft Guidance for Sponsors and Other Stakeholders on Using Registries as RWD to Support Regulatory Decision-Making

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The U.S. Food and Drug Administration (FDA) issued its third draft guidance under the Real-World Evidence (RWE) Program on November 29, 2021. In Real-World Data: Assessing Registries to Support Regulatory Decision-Making for...more

Faegre Drinker Biddle & Reath LLP

FDA Releases Draft Guidance for Sponsors on How to Comply with Study Data Standards When Submitting RWD-Sourced Study Data

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The U.S. Food and Drug Administration (FDA) issued a draft guidance titled Data Standards for Drug and Biological Product Submissions Containing Real-World Data on October 21, 2021. The guidance provides the Agency’s thoughts...more

Faegre Drinker Biddle & Reath LLP

FDA Posts Draft Guidance for Pharma Companies, Sponsors, and Researchers on Using Real-World Data from Health Records in Clinical...

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The U.S. Food and Drug Administration (FDA) has issued a draft guidance for pharmaceutical companies, sponsors, and researchers sourcing Real World Data (RWD) from health records. As the FDA’s first attempt to define...more

BakerHostetler

FDA Provides Playbook for Developing Cannabis Drugs

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The U.S. Food and Drug Administration (FDA) recently released the Draft Guidance for Industry, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. In this guidance, the FDA defers to the...more

Wilson Sonsini Goodrich & Rosati

FDA Outlines Considerations for the Development and Labeling of Companion Diagnostics for Use with a Specific Group or Class of...

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Recently, the U.S. Food and Drug Administration, or FDA, issued a draft guidance (the guidance) outlining considerations for the development and labeling of in vitro companion diagnostics to support indicated uses for...more

Jones Day

FDA Draft Guidance Regarding Inclusion of Pregnant Women in Clinical Trials

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The Situation: Pregnant women have historically been excluded from clinical trials due to concerns about the potential for adverse effects on pregnant women and their fetuses. The Development: The U.S. Food and Drug...more

Goodwin

FDA Issues Draft Guidances on Targeted Therapies and the Use of Standards

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The FDA published two draft guidances for comment this week: “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease” and “Standards Development and the Use of Standards in Regulatory Submissions...more

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