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Food and Drug Administration (FDA) › Public Comment › New Guidance

Gardner Law

FDA Guidance for Labeling Plant-based Products

Gardner Law on

The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, seafood, poultry, meat and dairy (excluding plant-based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

Wiley Rein LLP

FDA Updates Final Guidance on Cosmetic Facility Registration and Product Listing: Wiley

Wiley Rein LLP on

The Food and Drug Administration (FDA) recently issued a Notice announcing the availability of an updated final guidance for the industry entitled “Registration and Listing of Cosmetic Product Facilities and Products.” The...more

Morgan Lewis - Well Done

FDA Issues Guidance on Foods Made from Genome-Edited Plants in Newest Update to Its ‘Plant-Based Cookbook’

Morgan Lewis - Well Done on

The US Food and Drug Administration (FDA) issued final guidance titled Foods Derived from Plants Produced Using Genome Editing (Genome-Edited Plants Guidance), describing the agency’s approach for evaluating the safety of...more

BakerHostetler

Navigating the FDA’s SIUU Guidance: Key Insights for Pharma and MedTech

BakerHostetler on

On Oct. 23, the FDA issued draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses [SIUU] of Approved/Cleared Medical Products: Questions and Answers,”...more

Hogan Lovells

FDA issues final and draft guidance on allergen labeling requirements

Hogan Lovells on

On November 29, the U.S. Food and Drug Administration (FDA) issued two guidance documents about food allergen labeling requirements. First, FDA issued a draft guidance titled Questions and Answers Regarding Food Allergens,...more

McDermott Will & Schulte

FDA Issues Good Machine Learning Practice Guiding Principles

McDermott Will & Schulte on

On October 27, 2021, pursuant to the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan (Action Plan), the US Food and Drug Administration (FDA) released its Good Machine Learning...more

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

On June 24, 2021, the Food and Drug Administration (FDA) issued the long-awaited Remanufacturing of Medical Devices Draft Guidance (Draft Remanufacturing Guidance), which describes the agency’s current thinking on activities...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 16, Number 12. In This Month's E-News: December 2019

Health Care Compliance Association (HCCA) on

Report on Research Compliance 16, no. 12 (December 2019) - NIH is seeking comment on a proposed policy for data management and sharing, as well as two related guidance documents that together seek to “promote effective and...more

Holland & Knight LLP

FDA Guidance on DSCSA Product Identifier Requirements

Holland & Knight LLP on

Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more

Patterson Belknap Webb & Tyler LLP

FDA Approach to Labeling Treats Biosimilars Like Generics

Patterson Belknap Webb & Tyler LLP on

One of the FDA’s recent biosimilar guidance documents has drawn criticism for eliminating labeling information necessary for physicians to make prescribing decisions. The guidance document, titled, “Scientific Considerations...more

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