News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Proposed Legislation Regulatory Oversight

Akin Gump Strauss Hauer & Feld LLP

Congress Joins FDA in Focusing on Food Dye Limitations

Food dye reform has been an area of focus for the Trump administration as part of its Make America Healthy Again (MAHA) initiative, giving momentum to an effort the Food and Drug Administration (FDA) had already started by...more

ArentFox Schiff

FDA Seeks to Increase Regulatory Oversight of Laboratory Developed Tests

ArentFox Schiff on

On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs). In this proposed rule, the FDA announced its intent to amend its regulations to...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Foley Hoag LLP

Congress Adds Some Teeth to FDA’s Authority to Regulate Cosmetics

Foley Hoag LLP on

The Food and Drug Administration (FDA) now has additional regulatory authorities over cosmetics, thanks to the Food and Drug Omnibus Reform Act (FDORA). FDORA was a part of the Consolidated Appropriations Act, 2023 (the...more

Seyfarth Shaw LLP

Seyfarth on CBD – February 2020 Update

Seyfarth Shaw LLP on

CBD continues to flourish in the markets despite lack of federal regulations, and we’ve identified some significant events that indicate there’s no sign it’s stopping. ...more

Robinson+Cole Health Law Diagnosis

Bipartisan Bill for Federal Regulation of CBD in Foods and Dietary Supplements

A bipartisan bill was introduced in the U.S. House of Representatives on January 13, 2020, that (1) would allow hemp-derived cannabidiol (CBD) to be regulated as a dietary supplement, if all of the other applicable...more

Seyfarth Shaw LLP

A Celebrity Visit to D.C. Calls Attention to Cosmetics Regulations Reform

Seyfarth Shaw LLP on

Seyfarth Synopsis: What brings a celebrity to the Hill? A look at the current state of cosmetics regulations and potential effects of the Personal Care Products Safety Act that has gained famous support. ...more

Troutman Pepper Locke

Right to Try Legislation: Worthwhile or Window Dressing?

Troutman Pepper Locke on

"Right to Try" legislation, which enables terminally ill patients or patients with a "life threatening disease or condition" to seek access to investigative drugs with little to no oversight from the FDA, has been enacted in...more

Hogan Lovells

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

Hogan Lovells on

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills...more

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