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Regulatory Reform › Pharmaceutical Industry › Comment Period

Wilson Sonsini Goodrich & Rosati

FDA Launches PreCheck and Advanced Manufacturing Technologies Designation Programs to Strengthen U.S. Drug Manufacturing

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The U.S. Food and Drug Administration (FDA) recently announced two initiatives to boost domestic pharmaceutical production. On August 7, 2025, the agency announced the voluntary FDA PreCheck Program to expedite review of new...more

Quarles & Brady LLP

Alabama Board of Pharmacy Issues Non-Disciplinary Fine Schedule

Quarles & Brady LLP on

On August 20, 2025, the Alabama Board of Pharmacy (the “Board”) issued its long-awaited non-disciplinary penalty schedule via emergency rulemaking. The rule went into effect immediately and will expire on December 18, 2025....more

Mintz - Health Care Viewpoints

FDA in Flux — August 2025 Newsletter

Mintz - Health Care Viewpoints on

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more

Katten Muchin Rosenman LLP

Fast-Lane Approval to Boost U.S. Drug Manufacturing and Supply Chain Security

Katten Muchin Rosenman LLP on

On August 7, 2025, the Food and Drug Administration announced a voluntary “FDA Pre-Check” program to encourage and expedite domestic drug manufacturing by offering qualifying facilities a more predictable, risk-based...more

Jones Day

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

Jones Day on

The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

Nelson Mullins Riley & Scarborough LLP

FDA Revises Guidance Concerning Scientific Communications to HCPs about Unapproved Uses of Approved/Cleared Medical Products

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The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more

Nelson Mullins Riley & Scarborough LLP

FDA Publishes Groundbreaking AI/ML Medical Device Draft Guidance

Nelson Mullins Riley & Scarborough LLP on

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

Nelson Mullins Riley & Scarborough LLP on

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

Knobbe Martens

FDA Draft Guidance for Fostering Medical Device Improvement Using the Voluntary Improvement Program

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On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program (“VIP”). The draft guidance, Fostering Medical Device Improvement: FDA...more

Arnall Golden Gregory LLP

Roll With the Changes: FDA’s Proposed Amendments to Converge its Quality Management System Requirements With ISO Requirements

Arnall Golden Gregory LLP on

In the words of the rock band REO Speedwagon, from the 1978 song “Roll with the Changes,” “It had to happen, felt the tables turnin’.” Earlier this month, the Food and Drug Administration’s Device Good Manufacturing Practice...more

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