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Regulatory Requirements › Clinical Trials › New Guidance

Akin Gump Strauss Hauer & Feld LLP

FDA Continues Focus on Rare Disease Drug Development, Announces Evidence Principles

Akin Gump Strauss Hauer & Feld LLP on

On September 3, 2025, the Food and Drug Administration (FDA) announced Rare Disease Evidence Principles (RDEP) with processes aimed at providing greater predictability and facilitating the development and review of drugs...more

Morgan Lewis

FDA Regulatory Uncertainty Calls for Strategic Decision-Making by Drug Developers

Morgan Lewis on

The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more

Knobbe Martens

FDA Publishes Case Studies and User Guide for Rare Disease Drug Developers

Knobbe Martens on

Drug development programs face unique challenges in demonstrating the safety and effectiveness of drugs for treating rare diseases. The FDA’s Accelerating Rare disease Cures (ARC) Program started the Learning and Education to...more

Ropes & Gray LLP

FDA Issues Draft Guidance Describing When a Confirmatory Trial of a Drug Seeking Accelerated Approval Is “Underway”

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In recent years, Congress and the U.S. Food and Drug Administration (“FDA”) have sought to reform the accelerated approval process, an expedited development and approval pathway for drugs that provide meaningful therapeutic...more

Sheppard Mullin Richter & Hampton LLP

FDA Furthers Efforts to Improve the Accelerated Approval Pathway through New Draft Guidance on Confirmatory Trials

Sheppard Mullin Richter & Hampton LLP on

On January 6, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway” (the “Draft...more

Akin Gump Strauss Hauer & Feld LLP

FDA Announces Draft Guidance on Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial Is Underway

Akin Gump Strauss Hauer & Feld LLP on

On January 6, the FDA announced the availability of draft guidance on accelerated approval for drugs and biological products, and consideration for determining whether a confirmatory trial is underway. Under the Consolidated...more

McDermott Will & Schulte

FDA Issues Final Guidance on Informed Consent in Clinical Investigations

McDermott Will & Schulte on

On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more

Haug Partners LLP

Understanding the FDA’s Medical Products Clinical Trial Guidance amidst COVID-19

Haug Partners LLP on

Conducting medical product clinical trials during the COVID-19 public health emergency presents unprecedented challenges. In light of the challenges presented by COVID-19, the Food and Drug Administration (FDA) issued...more

Hogan Lovells

FDA details recommendations for live case presentations during medical device clinical trials in final guidance

Hogan Lovells on

This month, the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance on live case presentations as part of clinical trials conducted under an approved (or conditionally approved) investigational...more

Hogan Lovells

NIH issues long-awaited guidance on other support, foreign components, and financial conflicts of interest

Hogan Lovells on

On 10 July 2019 the National Institutes of Health (NIH) issued its long-awaited guidance addressing grantee disclosure obligations related to researchers' activities outside the United States. ...more

Hogan Lovells

UK Government Publishes Guidance for Life Sciences Companies on Brexit Transition

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The UK Government has published guidance for life sciences companies on the Brexit implementation period, which is intended to take effect from 30 March 2019 to the end of 2020. ...more

Bricker Graydon LLP

FDA issues guidance on use of EHR data in clinical research

Bricker Graydon LLP on

Many hospitals and health systems conduct sponsored clinical research at their facilities, and clinical trial agreements typically require that sponsors and clinical investigators have access to certain data regarding the...more

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