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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

Troutman Pepper Locke

Embattled Biotechs Facing Uncertainty at the FDA Look to Collaborative Deal Structures

Troutman Pepper Locke on

Biotechs have faced several challenging years with slumping valuations and a competitive funding environment. However, the latest slew of retirements and layoffs at the FDA could present their greatest challenge yet....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

Skadden, Arps, Slate, Meagher & Flom LLP

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

Skadden, Arps, Slate, Meagher & Flom LLP on

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

Mintz - Health Care Viewpoints

OHRP Workshop Highlights Artificial Intelligence Uses, Concerns in Human Research

Mintz - Health Care Viewpoints on

The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) recently held its 2024 Exploratory Workshop titled “The Evolving Landscape of Human Research with AI – Putting Ethics to Practice”...more

Gardner Law

FDA's View on Cannabis

Gardner Law on

The U.S. Food and Drug Administration (FDA) is continuing to support clinical research for cannabis and psychedelic drug development. On the heels of publishing its first draft guidance on clinical trials involving...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 - ML Strategies

ML Strategies Outlook for 2024

Mintz - ML Strategies on

Congress — Big Agenda & Little Time - With the holidays behind us, Congress returned this week for the second half of the 118th Congress with a long list of items to address and, as the 2024 campaign season ramps up, limited...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

McGlinchey Stafford

Is THCA Legal? The State Line is the Bottom Line

McGlinchey Stafford on

Tetrahydrocannabinolic acid (THCA) is one of the most misunderstood and controversial cannabinoids in the Cannabis sativa (cannabis) plant. While booming in popularity, THCA is also a high-risk cannabinoid from a legal...more

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

Regulating AI: An Overview of Federal Efforts

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

This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...more

BakerHostetler

Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products

BakerHostetler on

On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between...more

Vicente LLP

Understanding the Current Legal Status of Psychedelics in the United States

Vicente LLP on

In a previous article, we explored one potential current opportunity for entrepreneurs interested in psychedelics and mycelium—producing non-psychoactive mushroom supplements. But are there any current commercial...more

Maynard Nexsen

The Impact of COVID-19 on Clinical Research in the Life Sciences Industry: Is there a Silver Lining?

Maynard Nexsen on

Clinical research is one of the foundations of the Life Sciences industry as it involves the scientific investigation and treatment of diseases and other medical conditions in order to improve medical knowledge related to the...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Research Compliance Academy - December 13th - 16th, Las Vegas, NV

Health Care Compliance Association (HCCA) on

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day intensive training program designed to help attendees increase their ability to manage effective research compliance programs. Our faculty of experts...more

Skadden, Arps, Slate, Meagher & Flom LLP

HKEx Reforms Attract High-Profile Technology and Biotech Listings

Skadden, Arps, Slate, Meagher & Flom LLP on

In the past year, nearly a dozen companies have taken advantage of new rules to list on the Stock Exchange of Hong Kong Limited (HKEx). On April 30, 2018, HKEx introduced a series of reforms to encourage the listing of...more

Searcy Denney Scarola Barnhart & Shipley

Hacking Gains New Heights with Threat to Big Pharma

Searcy Denney Scarola Barnhart & Shipley on

Cyber attacks have broken free from their initial molds of carting off with consumer credit card numbers or stealing someone’s identity. The act of digitally digging into cyberspace has hit the U.S. Department of Health &...more

BakerHostetler

Pharmaceutical Life Cycle Management: Navigating the New IP, FDA and Antitrust Terrain

BakerHostetler on

Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications. In addition, negotiation of...more

McDonnell Boehnen Hulbert & Berghoff LLP

Guest Post: $2.6 Billion Per Drug: Is Your Patent Portfolio Strong Enough to Protect Your Investment?

McDonnell Boehnen Hulbert & Berghoff LLP on

Late last year, the Tufts Center for the Study of Drug Development (CSDD) released a number that would cause jaws to drop all around the healthcare world.  The estimated cost for developing a new drug was an astounding $2.558...more

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