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McDermott Will & Emery

Preparing for 2025: Key Trends in FDA Guidance Agendas

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In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities,...more

Sheppard Mullin Richter & Hampton LLP

FDA Dumps Trio of Device-Related Guidances Prior to Administration Change

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Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more

MoFo Life Sciences

FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety,...

MoFo Life Sciences on

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

Ropes & Gray LLP

FDA and OHRP Issue Draft Guidance on Including Biopsies in Clinical Trials

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On January 6, 2025, the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more

DLA Piper

Navigating China's Healthcare Compliance Landscape: New Guidelines to Mitigate Commercial Bribery Risks

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China's State Administration for Market Regulation (SAMR) has released the draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (Draft Guidelines) for public comment. The Draft Guidelines,...more

Sheppard Mullin Richter & Hampton LLP

New Accelerated Approval Guidance Underscores Need for Accountability

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On December 5, 2024, just in time for the holidays, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Expedited Program for Serious Conditions: Accelerated Approval of Drugs and...more

Quarles & Brady LLP

FDA Releases Draft Interim Guidance on Bulk Drug Substances in Compounding Under Sections 503A and 503B of FDCA

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The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act...more

Sheppard Mullin Richter & Hampton LLP

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

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On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more

Nelson Mullins Riley & Scarborough LLP

FDA Publishes Groundbreaking AI/ML Medical Device Draft Guidance

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The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more

Nelson Mullins Riley & Scarborough LLP

FDA Revamps Guidance Concerning Use of Electronic Systems, Records, and Signatures in Clinical Investigations

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The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (Draft...more

Arnall Golden Gregory LLP

Break On Through to the Other Side, Part 2: FDA Issues Draft Guidance About Breakthrough Therapy Designation Rescission

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In September 2014, AGG prepared a Bulletin on the Food and Drug Administration’s Breakthrough Therapy Designation (BTD) program, referencing The Doors’ “Break On Through to the Other Side.” Time for Part 2. FDA issued a draft...more

McDermott Will & Emery

Special Report: Developments in UK Life Sciences – Spring Update 2022

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MHRA LAUNCHES UK CLINICAL TRIAL REGULATION CONSULTATION - The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom),...more

Arnall Golden Gregory LLP

The Room Where It Happens: FDA Issues Draft Guidance on Formal Meetings Between FDA and Sponsors of OTC Monograph Drugs

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The Food and Drug Administration let sponsors and requestors of over-the-counter (“OTC”) monograph drugs know how to be in the room where it happens when it issued a draft guidance this month on “Formal Meetings Between FDA...more

Mintz - Health Care Viewpoints

Evolution & Revolution: Device Policy Priorities at FDA in 2019

Mintz - Health Care Viewpoints on

This post is the first in a series of three in which we recap the Food and Drug Administration’s somewhat difficult year, having spent the majority of it without a permanent Commissioner and facing a slew of political and...more

Hogan Lovells

New draft guidance on MR compatibility for medical devices

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The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." ...more

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