News & Analysis as of

Research and Development › Food and Drug Administration (FDA) › Federal Food Drug and Cosmetic Act (FFDCA)

Perkins Coie

Caffeine Safety Legislation Introduced in Congress

Perkins Coie on

On March 31, 2025, Congress saw the reintroduction of H.R. 2511, the Sarah Katz Caffeine Safety Act. The bill would amend the Federal Food, Drug, and Cosmetic Act to establish new regulatory requirements for labeling the...more

Knobbe Martens

FDA Publishes Case Studies and User Guide for Rare Disease Drug Developers

Knobbe Martens on

Drug development programs face unique challenges in demonstrating the safety and effectiveness of drugs for treating rare diseases. The FDA’s Accelerating Rare disease Cures (ARC) Program started the Learning and Education to...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

Foley Hoag LLP

Information Collection Request for Drug Price Negotiation Program Data Elements

Foley Hoag LLP on

On March 21, 2023, CMS published in the Federal Register the Information Collection Request (ICR) Form, as required by the Paperwork Reduction Act, for Negotiation Data Elements under Sections 11001 and 11002 of the Inflation...more

Hogan Lovells

FDA authority to conduct bioresearch monitoring inspections expanded by appropriations legislation

Hogan Lovells on

U.S. President Biden recently enacted the “Consolidated Appropriations Act, 2023,” a $1.7 trillion omnibus funding bill that contains the Food and Drug Omnibus Reform Act (FDORA). Below we analyze how Section 3612 of FDORA,...more

Foley & Lardner LLP

Psychedelic Drugs – Easing the Regulatory Hurdles for Development

Foley & Lardner LLP on

Congress recently introduced a bill that could expand access to therapeutic psychedelics that are designated as Breakthrough Therapies. These products are potentially useful in treating addiction, depression, post-traumatic...more

King & Spalding

Congress Holds Hearing on Current & Future Federal Cannabis Policies

King & Spalding on

On January 15, 2020, the House Energy & Commerce Committee, Subcommittee on Health held a hearing entitled “Cannabis Policies for the New Decade.” Government witnesses testified from: • the Drug Enforcement...more

Steptoe & Johnson PLLC

FDA Holds First Public Hearing on CBD Regulation

Steptoe & Johnson PLLC on

As the market for Cannabidiol (CBD) products continues to rapidly expand across the country, federal agencies are in the early phase of establishing regulations for the processing, dispensing, and ingestion of CBD products....more

Mintz - Health Care Viewpoints

21st Century Cures Act Requires FDA to Expand the Role of Real World Evidence

Mintz - Health Care Viewpoints on

As we noted in our December 9th post, the 21st Century Cures Act (the “Cures Act”) requires FDA to develop a framework and guidance for evaluating real world evidence (“RWE”) in the context of drug regulation to support...more

10 Results
 / 
View per page
Page: of 1

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

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide