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Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Ropes & Gray LLP

FDA Finalizes Guidance on Remote Regulatory Assessments, But How Will They Support the Administration’s Manufacturing-Related...

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In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more

McCarter & English, LLP

FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

McCarter & English, LLP on

In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more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

Nelson Mullins Riley & Scarborough LLP

FDA Publishes Informed Consent Final Guidance for Drug and Medical Device Clinical Investigations

Nelson Mullins Riley & Scarborough LLP on

The U.S. Food and Drug Administration (FDA or the Agency) has issued the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final Guidance). The...more

Hogan Lovells

FDA publishes final guidance on ANDA/505(b)(2) NDA pathways

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On Thursday, FDA published the final guidance document, “Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor revisions to the October 2017 draft guidance. ...more

Hogan Lovells

FDA Finalizes Data Integrity Guidance, With Some Noteworthy Changes

Hogan Lovells on

Earlier yesterday, FDA published the final guidance “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” which updates April 2016 draft guidance that covers the design, operation, and monitoring of systems...more

Hogan Lovells

Institutional Review Board “Checklist” offers tool to help protect clinical trial participants

Hogan Lovells on

On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). ...more

Mintz - Health Care Viewpoints

Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps

Mintz - Health Care Viewpoints on

This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you...more

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