News & Analysis as of

Food and Drug Administration (FDA) Proposed Legislation European Union

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2025 and Beyond

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

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2024 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. ...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 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

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 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

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

Goodwin

US Artificial Intelligence Regulations: Watch List for 2023

Goodwin on

Companies are developing, deploying, and interacting with artificial intelligence (AI) technologies more than ever. At Goodwin, we are keeping a close eye on any regulations that may affect companies operating in this...more

Venable LLP

Senator Mike Lee Introduces the Biosimilar Red Tape Elimination Act to Eliminate Switching Study Requirement for Biosimilar...

Venable LLP on

On November 17, 2022, Senator Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase biosimilar competition and reduce patient costs by prohibiting the FDA from requiring switching studies to approve...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l August 2019

LEGISLATION, REGULATIONS & STANDARDS - Bipartisan Bill Introduced to Standardize Food Date Labels - U.S. Reps. Chellie Pingree (D-Maine) and Dan Newhouse (R-Wash.) have introduced the Food Date Labeling Act, which aims...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l May 2019 #3

L E G I S L A T I O N , R E G U L A T I O N S & S T A N D A R D S - FDA Issues Guidance On “Potassium Chloride Salt” - The U.S. Food and Drug Administration (FDA) has issued draft guidance for industry on the use of...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | March 2018

Senate Committee Proposes Cosmetics Regulation Amendment - The Senate Committee on Health has released a discussion draft of a proposed amendment to the Federal Food, Drug and Cosmetic Act (FDCA) that would establish greater...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | December 2017

Sen. Hatch Introduces New Bill Regulating Cosmetic Safety - Sen. Orrin Hatch (R-Utah) has introduced legislation aiming to modernize cosmetics regulation, proposing amendments to the Federal Food, Drug and Cosmetic Act...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | July 2017 #2

GE Salmon Bill Introduced in U.S. Senate - A bipartisan group of U.S. senators has introduced a bill that would require labeling of genetically engineered (GE) salmon and independent scientific review of the U.S. Food and...more

Goodwin

USP Says European Market Shows Mandatory USP Standards Would Improve Biosimilar Approval, Acceptance in U.S.

Goodwin on

Back in March, 2016, the Senate added language to the FDA and NIH Workforce Authorities Modernization Act which would exempt biological products, including biosimilars, from provisions of the FDCA Act that require compliance...more

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