Proposed Regulation, Food and Drug Administration (FDA), Federal Food Drug and Cosmetic Act (FFDCA)

Imported Drugs: (Possibly) Coming Soon to a State Near You

McDermott Will & Emery on 4/8/2024

In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from...more

New Animal Feed Proposal Introduced in US House

Perkins Coie on 12/27/2023

On December 7, U.S. Representative Greg Pence (R-IN) introduced the Innovative Feed Enhancement and Economic Development Act of 2023 (the Innovative FEED Act). Sen. Roger Marshall (R-KS) introduced the Senate version of the...more

Industry Anticipates Impending FDA Proposed Regulation Addressing Laboratory Developed Tests

Jones Day on 8/31/2023

Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...more

FDA Regulation of CBD is TBD

Lippes Mathias LLP on 3/21/2023

After rounding out 2022 with a series of warning letters to companies selling products containing cannabidiol (“CBD”) the U.S. Food and Drug Administration (“FDA”) began 2023 by issuing a press release announcing its...more

Half-Baked: An Overview of Current Cannabinoid Laws & Regulations

Butler Snow LLP on 12/9/2022

Over 50 years ago President Nixon declared a “War on Drugs,” leaving housewives over the country proclaiming marijuana to be the devil’s lettuce and urging sweet Billy to steer clear of the gateway drug...more

The Wait is Over: FDA Releases Proposed Rule to Align the U.S. Medical Device Quality Regulation with International Standards

King & Spalding on 3/2/2022

On February 23, 2022, the U.S. Food and Drug Administration (FDA) published in the Federal Register, 87 Fed. Reg. 10119, the long-awaited proposed rule, Medical Devices; Quality System Regulation Amendments (Docket No....more

GAO Report Sheds Light on Drug Manufacturers’ Expanded Access Programs

Mintz - Health Care Viewpoints on 9/17/2019

Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside of the context of formal clinical trials,...more

Will Your No-Smoking Policy Get Vaporized?

Fisher Phillips on 5/12/2015

Wondering what your employee is smoking in the break room, likely in violation of your “no-smoking” policy? Chances are it is an electronic smoking device, such as an e-cigarette or vaporizer. What should you do about it?...more

Proposed Regulation › Food and Drug Administration (FDA) › Federal Food Drug and Cosmetic Act (FFDCA)

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