News & Analysis as of

Public Comment Life Sciences Draft Guidance

Sterne, Kessler, Goldstein & Fox P.L.L.C.

FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...more

Nelson Mullins Riley & Scarborough LLP

FDA Publishes Groundbreaking AI/ML Medical Device Draft Guidance

The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more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

The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (Draft...more

Nelson Mullins Riley & Scarborough LLP

FDA Revises Recommendations Regarding Electronic Systems, Records, and Signatures in Clinical Investigations

On March 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued updated draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (“Draft...more

Goodwin

Safety First! Much-Anticipated FDA Draft Guidance Provides Additional Advice on the Development of Human Genome Editing Products

Goodwin on

Last week the U.S. Food and Drug Administration (FDA) issued a long-awaited draft guidance, Human Gene Therapy Products Incorporating Human Genome Editing, that addresses key considerations for the development of gene therapy...more

Mintz - Health Care Viewpoints

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

On June 24, 2021, the Food and Drug Administration (FDA) issued the long-awaited Remanufacturing of Medical Devices Draft Guidance (Draft Remanufacturing Guidance), which describes the agency’s current thinking on activities...more

Harris Beach Murtha PLLC

FDA Proposes Strengthening Warning Labels on Breast Implants

Harris Beach Murtha PLLC on

The Food and Drug Administration has issued a new draft breast implant guidance recommending that manufacturers strengthen labeling about the potential complications and risks of the medical devices, particularly by adding...more

Foley & Lardner LLP

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

Foley & Lardner LLP on

Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more

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