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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

Arnall Golden Gregory LLP

AGG Talks: Cross-Border Business Podcast - Episode 27: U.S. Healthcare Reimbursement Guidance for Foreign Life Sciences Companies

Arnall Golden Gregory LLP on

In this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by Andrew Tsui, AGG Healthcare Litigation partner, to explore the intricacies of reimbursement in the U.S....more

Morgan Lewis - As Prescribed

FDA’s Recent Guidance on Accelerated Approval and Implications for Rare Diseases

Morgan Lewis - As Prescribed on

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

McDermott Will & Schulte

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

McDermott Will & Schulte on

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

McDermott Will & Schulte

End of an Era: FDA Retires 2017 Interim Policies for Bulk Drug Lists

McDermott Will & Schulte on

On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk drug lists, announcing the end of FDA’s 2017 interim policies. Under the new...more

Hogan Lovells

MHRA publishes guidance on to new UK medical device post-market surveillance requirements

Hogan Lovells on

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a suite of guidance specifically designed to help medical device manufacturers understand and prepare for the new post-market surveillance (“PMS”)...more

Ropes & Gray LLP

FDA Issues Draft Guidance Describing When a Confirmatory Trial of a Drug Seeking Accelerated Approval Is “Underway”

Ropes & Gray LLP on

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 Unveils Draft Guidance on Developing Drugs and Biological Products for Weight Reduction

Akin Gump Strauss Hauer & Feld LLP on

On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...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

Hogan Lovells

FDA issues Guidance on Interim Animal Food Ingredient Consultation (AFIC) Process

Hogan Lovells on

On January 6, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) issued its final guidance on the interim Animal Food Ingredient Consultation (AFIC) process, which FDA positions as a...more

Troutman Pepper Locke

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...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

Quarles & Brady LLP

FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

Quarles & Brady LLP on

On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more

Mintz - Health Care Viewpoints

Are You a Medical Device Servicer or Remanufacturer? FDA’s New Guidance May Help…Or Not

Mintz - Health Care Viewpoints on

On June 24, 2021, the Food and Drug Administration (FDA) issued the long-awaited Remanufacturing of Medical Devices Draft Guidance (Draft Remanufacturing Guidance), which describes the agency’s current thinking on activities...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

Polsinelli

FDA Publishes Industry Guidance Document for Amendments to Abbreviated New Drug Applications

Polsinelli on

In early July 2018, the United States Food and Drug Administration (FDA) issued a final guidance document titled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA – Guidance for Industry." A...more

Hogan Lovells

UK Government Publishes Guidance for Life Sciences Companies on Brexit Transition

Hogan Lovells on

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

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