News & Analysis as of

Manufacturers Labeling Comment Period

Davis Wright Tremaine LLP

EPA Seeks Comments on "Clean" Label for Construction Industry

Inflation Reduction Act pledged millions to label program intended to cut climate pollution linked to manufacturing of construction products and materials - The Environmental Protection Agency ("EPA") is seeking public...more

BakerHostetler

Transforming Cosmetics Regulation: FDA’s Mandatory Compliance Shift for Safer Beauty

BakerHostetler on

On August 7, 2023, the U.S. Food and Drug Administration (FDA, the Agency) published draft guidance aimed at assisting cosmetics companies with achieving and maintaining compliance with new cosmetic product facility...more

Smart & Biggar

Health Canada Consultation on Electronic Media in Prescription Drug Labelling

Smart & Biggar on

On March 12, 2021, Health Canada released for consultation its new Draft Guidance Document on Electronic media in prescription drug labelling. The draft Guidance sets out Health Canada’s expectations for drug manufacturers...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues New Draft Cybersecurity Guidance for Medical Devices

The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more

McDermott Will & Emery

TTB Reopens Comment Period for Three Notices of Proposed Rulemaking

McDermott Will & Emery on

On October 11, 2017, the Alcohol and Tobacco Tax and Trade Bureau (TTB) reopened the comment period for the following three notices of proposed rulemaking... ...more

Arnall Golden Gregory LLP

Talk This Way: FDA Provides Guidelines on Medical Product Communications Consistent With the FDA-Required Labeling

Channeling Aerosmith’s 1975 single, “Walk This Way,” and the song lyric “Talk This Way,” the Food and Drug Administration issued a draft guidance to industry on how it can communicate certain types of product information...more

Troutman Pepper

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

Troutman Pepper on

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

Cozen O'Connor

New FDA Draft Guidance on Updates to Certain Generic Labeling

Cozen O'Connor on

On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for...more

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