Regulatory Requirements, Public Comment, Draft Guidance

FDA Guidance for Labeling Plant-based Products

Gardner Law on 3/13/2025

The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, seafood, poultry, meat and dairy (excluding plant-based milk, e.g. oat milk). FDA is...more

FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

Sterne, Kessler, Goldstein & Fox P.L.L.C. on 1/15/2025

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s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

FDA and Prescription Drug Use Related Software – FDA’s Draft PDURS Guidance Answers Years-Old Questions and Introduces New Ones

Foley Hoag LLP on 9/26/2023

After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more

Health Care Triage: Highlights for Research Institutions and Sponsors in FDA's Recent Draft Guidance on Decentralized Clinical...

K&L Gates LLP on 6/1/2023

In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical...more

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

Mintz - Health Care Viewpoints on 7/23/2021

On June 24, 2021, the Food and Drug Administration (FDA) issued the long-awaited Remanufacturing of Medical Devices Draft Guidance (Draft Remanufacturing Guidance), which describes the agency’s current thinking on activities...more

FDA Updates Digital Health Guidances to Align with 21st Century Cures Act

Mintz - Health Care Viewpoints on 10/10/2019

On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following: - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act...more

New Draft Policy on Clinical Decision Support Software Highlights FDA’s Release of Six New Digital Health Guidance Documents

Akin Gump Strauss Hauer & Feld LLP on 10/8/2019

• The FDA recently issued six guidance documents that further clarify the agency’s interpretation of the 21st Century Cures Act’s software exemptions. • The revised draft guidance on CDS further elaborates on how to make CDS...more

Regulatory Requirements › Public Comment › Draft Guidance

FDA Guidance for Labeling Plant-based Products

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

FDA and Prescription Drug Use Related Software – FDA’s Draft PDURS Guidance Answers Years-Old Questions and Introduces New Ones

Health Care Triage: Highlights for Research Institutions and Sponsors in FDA's Recent Draft Guidance on Decentralized Clinical...

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

FDA Updates Digital Health Guidances to Align with 21st Century Cures Act

New Draft Policy on Clinical Decision Support Software Highlights FDA’s Release of Six New Digital Health Guidance Documents

FDA Issues Series of Guidance Documents Aimed at Medical Software Regulation

FDA Guidance on DSCSA Product Identifier Requirements

New Proposed DoD Cyber Guidance May Fuel Bid Protest Docket

Regulatory Requirements › Public Comment › Draft Guidance

"My best business intelligence, in one easy email…"