News & Analysis as of

Today's Popular Updates › Clinical Trials

A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +
A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous thirty days. less -
Rothwell, Figg, Ernst & Manbeck, P.C.

Beyond Guinea Pigs: Patent Risks and Opportunities in AI-Enabled Drug Development

Rothwell, Figg, Ernst & Manbeck, P.C. on

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This...more

Hogan Lovells

Life Sciences Law Update Key developments for pharma and medical device companies in EU and Germany, France, UK, Italy and Spain...

Hogan Lovells on

Pharma: Reform of the EU Pharmaceutical Legislation; German Medical Research Act enacted fostering R&D also including confidentiality of drug prices; France adopts standard CTA clauses; UK easing clinical trials; Devices:...more

Foley & Lardner LLP

Navigating FDA’s Proposed Guidance on AI and Non-Animal Models: Safeguarding Innovation in Drug Development

Foley & Lardner LLP on

In April 2025, the U.S. Food and Drug Administration (FDA) released a landmark guidance titled “Roadmap to Reducing Animal Testing in Preclinical Safety Studies,” outlining its commitment to advancing New Approach...more

Mintz - Health Care Viewpoints

FDA in Flux — July 2025 Newsletter

Mintz - Health Care Viewpoints on

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more

Woodruff Sawyer

Life Sciences Insurance: Navigating Risk from Lab to IPO

Woodruff Sawyer on

In our new webinar series, Risk Management for Your Life Sciences Company, we discuss the insurance and risk management milestones life science companies should prepare for as they move from early funding through clinical...more

Morrison & Foerster LLP

MAHA Commission Publishes Report to Highlight Childhood Chronic Disease Drivers

Morrison & Foerster LLP on

On May 22, 2025, President Trump’s Make America Healthy Again (MAHA) Commission released an assessment titled “The MAHA Report: Make Our Children Healthy Again Assessment.” The report—framed as a “call to action”—stems from a...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

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q1 2025

Bass, Berry & Sims PLC on

The healthcare mergers and acquisitions (M&A) market began 2025 with a slower start than expected given the easing headwinds and building momentum at the end of last year, with the number of deals reported in Q1 lower than...more

Ropes & Gray LLP

China Formalizes Regulatory Data Protection Mechanism

Ropes & Gray LLP on

Recently, the National Medical Products Administration (NMPA) issued the draft version of 'Implementation Measures for Drug Trial Data Protection (hereinafter referred to as the 'Draft for Comments'), aiming to clarify the...more

Stikeman Elliott LLP

Health Canada Consults on Pathway for Health Products Containing CBD

Stikeman Elliott LLP on

Health Canada recently announced that it is exploring a regulatory pathway that would allow products containing cannabidiol (“CBD”) to be purchased without a prescription. Under the current regulatory scheme, all health...more

Morgan Lewis

Drugs and Biologics at FDA: Reflections on 2024 Activity Shed Light on the Road Ahead

Morgan Lewis on

With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be no exception to this rule, and with its arrival we examine FDA’s activities...more

Foley & Lardner LLP

AI Drug Development: FDA Releases Draft Guidance

Foley & Lardner LLP on

On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...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

Hogan Lovells

JPM2025: Regulation of artificial intelligence: Navigating a new frontier in health care

Hogan Lovells on

Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI technologies rapidly evolve, global regulators face the complex task of regulating AI to...more

Arnall Golden Gregory LLP

Life in the Fast Lane: FDA Issues New Draft Guidance for Accelerated Approval of Drugs and Biologics

Arnall Golden Gregory LLP on

In 1976, the Eagles released the song, “Life in the Fast Lane,” as part of their iconic album, Hotel California. Approximately 16 years later, the Food and Drug Administration began offering pharmaceutical companies their own...more

Hogan Lovells

New FDA clinical trials guidances promote efficient drug development, innovative designs, diversity

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) issued this week three guidance documents related to clinical trials: a draft guidance on multiregional trials in oncology, a draft guidance on integrating randomized controlled...more

Womble Bond Dickinson

FDA Rejects MDMA Treatment for PTSD; Setbacks and New Directions

Womble Bond Dickinson on

In a previous blog on the use of psychedelics to treat mental health disorders, we reported that the US Food and Drug Administration (FDA) granted breakthrough therapy designation to MDMA (a.k.a., ecstasy) in 2017 as part of...more

Goodwin

FTC Comment on FDA Draft Guidance on Interchangeability

Goodwin on

We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more

Foley & Lardner LLP

Artificial Intelligence: Is the Health Care Sector Ready for the Rollout?

Foley & Lardner LLP on

On July 17, 2024, Foley & Lardner LLP hosted the Boston Health Care AI & Technology Investor Summit with Endeavor Venture Funds, bringing together hundreds of attendees in person and virtually to discuss issues surrounding...more

Foley & Lardner LLP

Clinical Trials: FDA Publishes Draft Guidance on Diversity Action Plans

Foley & Lardner LLP on

On June 26, 2024, the U.S. Food and Drug Administration (FDA) released draft guidance addressing use of diversity action plans (Plans) in the conduct of clinical research entitled “Diversity Action Plans to Improve Enrollment...more

Hogan Lovells

Top legal issues to think about in China-related licensing transactions

Hogan Lovells on

This article provides a general overview of certain Chinese legal considerations for licensing and collaboration deals in the life sciences industry. In particular, this article focuses on two types of transactions...more

Hogan Lovells

FDA AI & Medical Products Paper advocates for a tailored risk-based regulatory framework

Hogan Lovells on

The Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Office of Combination...more

Foley & Lardner LLP

Federal Circuit Applies Safe Harbor to Imported Medical Device Samples

Foley & Lardner LLP on

The “safe harbor” of 35 USC § 271(e)(1) shields certain acts from liability for patent infringement if they are conducted “solely for uses reasonably related” to obtaining U.S. Food and Drug Administration (FDA) approval to...more

Health Care Compliance Association (HCCA)

‘If Only She Could Have Been Stronger’: Miami Trial Fraud Leads to Prison, Personal Loss

Health Care Compliance Association (HCCA) on

In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more

Mintz - Health Care Viewpoints

FDA Needs a New Approach to AI/ML-Enabled Medical Devices

Mintz - Health Care Viewpoints on

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more

90 Results
 / 
View per page
Page: of 4
Next »

"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