News & Analysis as of

Regulatory Reform Today's Popular Updates Pharmaceutical Industry

McDermott+

Trump Administration Executive Order Tracker - updated 8.18.25

McDermott+ on

Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

Morrison & Foerster LLP

Top 10 International Anti-Corruption Developments for June 2025

Designed for busy in-house counsel, compliance professionals, and anti-corruption lawyers, this newsletter summarizes some of the most important international anti-corruption law and enforcement developments from the past...more

Smart & Biggar

Update on biosimilars in Canada – June 2025

Smart & Biggar on

This article provides an update on developments in the biosimilar space in Canada—regulatory, approvals, pending submissions, litigation, and market access—since our March 2024 update. Consultation on revised biosimilar...more

Brownstein Hyatt Farber Schreck

AmCham Forum Showcases Business Opportunities in Egypt

From May 25 to 26, the American Chamber of Commerce in Egypt (AmCham Egypt), in collaboration with the U.S. Chamber of Commerce, the U.S.-Egypt Business Council and the Egypt-U.S. Business Council, hosted the U.S.-Egypt...more

Hogan Lovells

EU Pharma Law Package: Council Position on Reduction of Regulatory Exclusivity Rights

Hogan Lovells on

On 4 June 2025, the Council of the EU adopted its position on the EU Pharma Law Package legislative proposal to revise the EU’s general pharmaceutical legislation. The Council, consisting of all the 27 EU Member States and...more

Polsinelli

The Trump Administration Announces Price Targets as It Takes a Second Swing at “Most Favored Nation” Drug Pricing Model

Polsinelli on

At a Glance - MFN Pricing Returns: The EO revives effort to link U.S. drug prices to those in peer countries, calling for voluntary industry action. Aggressive Action on the Table: If progress on voluntary price cuts...more

Latham & Watkins LLP

FDA and NIH Announce Initiatives to Reduce Animal Testing and Encourage Alternative Methodologies

Latham & Watkins LLP on

The initiatives reflect the latest measures from federal agencies to reduce and ultimately replace animal testing in drug development and biomedical research....more

Alston & Bird

Health Care Week in Review | Senate HELP Committee Chair Cassidy Calls for 340B Reforms; House Republicans Launch American-Made...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Gardner Law

FDA Layoffs, RFK Jr. at HHS, and What This Means for FDA-Regulated Companies

Gardner Law on

In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more

Skadden, Arps, Slate, Meagher & Flom LLP

Under RFK Jr., US Health Policy and FDA Operations May See Major Shifts

Robert F. Kennedy Jr. (RFK Jr.) has been confirmed by the Senate as secretary of the Department of Health and Human Services (HHS). In this capacity, RFK Jr. will oversee 13 agencies that are critical to U.S. health policy,...more

Cozen O'Connor

FDA Bans Red Dye No. 3 in Food and Ingested Drugs: What Manufacturers Should Know

Cozen O'Connor on

On January 16, 2025, the Food and Drug Administration (FDA) issued an order banning FD&C Red No.3 in food and ingested drugs.1 Food and ingested drug manufacturers who use Red No. 3 have until January 15, 2027, or January 18,...more

Hogan Lovells

FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research

Hogan Lovells on

U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more

13 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:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide