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FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?

A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU)

Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications - On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more

FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities

On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics (Draft Accelerated Approval...more

FDA Issues Updated Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs

On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more

Finally! FDA Issues Updated Draft Guidance on Diversity Action Plans Mandated by FDORA

On June 28, 2024, the U.S. Food and Drug Administration (FDA) announced in the Federal Register the issuance of a draft guidance entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented...more

LDT Final Rule: Shifting the LDT Battlefield

On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more

FDA Issues Draft Guidance on Use of Data Monitoring Committees in Clinical Trials

The U.S. Food and Drug Administration (FDA or Agency) has issued draft guidance, Use of Data Monitoring Committees in Clinical Trials, that applies to sponsors of clinical trials of investigational drugs, biologics, and...more

FDA Issues Proposed Rule Classifying Certain Wound Dressings and Liquid Wound Washes For the First Time

After enactment of the Medical Device Amendments of 1976, which established three regulatory classes for medical devices, the Food and Drug Administration (FDA) has been required to classify all medical devices into Class I,...more

FDA Issues Final Rule Permitting IRB Waiver or Alteration of Informed Consent for Certain Minimal Risk Clinical Investigations

The Food and Drug Administration (FDA) has issued a final rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, which allows an exception from the requirement to...more

Beyond Reprints for Scientific Information on Unapproved Uses of Medical Products

Revised Draft FDA Guidance Expands Scope of Permissible Proactive Off-Label Communications This week, FDA published new revised draft guidance, Communications From Firms to Health Care Providers Regarding Scientific...more

FDA Finalizes Premarket Cybersecurity Guidance for Medical Devices

On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). The Final Guidance replaces...more

FDA's Latest Salvo in the LDT Wars

On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more

FDA Finalizes Its Premarket Submissions Guidance for Medical Device Software Functions

On June 14, 2023, FDA finalized its “Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff” (the “2023 Final Guidance”). The Final Guidance replaces the...more

It’s Not Just for Dietary Supplements Anymore: FTC Revises and Expands Guidance for Health Claims

Signaling a renewed focus on consumer protection in the health claims space, the Federal Trade Commission (“FTC”) has revamped its 1998 guidance titled Dietary Supplements: An Advertising Guide for Industry and extended the...more

2022 Year in Review: FDA Drug and Device Advertising and Promotion Enforcement

In 2022, the U.S. Food and Drug Administration (FDA or the Agency) issued a total of nine enforcement letters targeting advertising and promotion violations for prescription drugs and devices.  A summary of the noteworthy...more

GAO Issues Report on Artificial Intelligence in Health Care

On September 29, 2022, the United States Government Accountability Office (“GAO”) and the National Academy of Medicine (“NAM”) jointly published a detailed Report to Congressional Requesters titled Artificial Intelligence in...more

FDA (Finally!) Issues Proposed Rule to Amend FDA Regulations on the Protection of Human Subjects and Institutional Review Boards

The Food and Drug Administration (FDA) recently issued a proposed rule that would extensively modify and modernize its current regulations governing the protection of human subjects and Institutional Review Boards (IRBs).1 If...more

FDA’s Final Clinical Decision Support Guidance: The Good News and the (Really) Bad News

On September 28, 2022, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited final guidance, “Clinical Decision Support Software” (the “Final CDS Guidance”). The Final CDS Guidance supersedes...more

France - A Charter for the Promotion of Medical Devices (Including IVD)

An ordinance (« arrêté ») was published in the French Official Gazette of 8 March 2022 that sets out a quality charter overseeing the professional practices of individuals responsible for the presentation of educational...more

The Wait is Over: FDA Releases Proposed Rule to Align the U.S. Medical Device Quality Regulation with International Standards

On February 23, 2022, the U.S. Food and Drug Administration (FDA) published in the Federal Register, 87 Fed. Reg. 10119, the long-awaited proposed rule, Medical Devices; Quality System Regulation Amendments (Docket No....more

A Pandemic Silver Lining: FDA’s New Guidance on Using Digital Health Technologies for Clinical Investigations

With spring timidly approaching, it’s hard not to dwell on the fact that we are almost two full years into the COVID-19 pandemic. The pandemic has placed into clear relief many of the access issues faced by patients and...more

A Magic Mixing Cauldron for the 21st Century: FDA’s new guidances on using real-world data in regulatory decision-making

In December 2016, fifteen Food and Drug Administration (FDA) officials, including then-Commissioner Robert Califf and current Acting Commissioner Janet Woodcock, published an article in the New England Journal of Medicine...more

FDA Issues New Draft Guidance for Sponsors on Safety Event Analysis and Reporting for IND and Bioavailability/Bioequivalence...

Focuses on Aggregate Safety Data Analysis and Expedited Reports; Expectation for Prospective Safety Surveillance Plan - The Food and Drug Administration (FDA) has issued a new draft guidance (the Draft Guidance) that...more

The End of Enforcement Discretion for Cell & Gene Therapies: Thinking Through Next Steps

Beginning this week, the U.S. Food and Drug Administration (“FDA”) ended its compliance and enforcement discretion policy with regard to certain human cell, tissue, and cellular and tissue-based products (“HCT/Ps”). HCT/P...more

FDA Reverses HHS Exemption of Class I and Class II Medical Devices from Section 510(k)

Premarket Notification Again Required for Patient and Surgeon's Examination Gloves and Dozens of Class II Devices Proposed for Exemption by Former HHS Secretary - On April 16, 2021, the Food and Drug Administration (“FDA”...more

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