News & Analysis as of

Life Sciences › Statutory Interpretation

Ropes & Gray LLP

Protecting Trade Secrets in FDA Submissions from FOIA Disclosure in the Wake of FDA Layoffs

Ropes & Gray LLP on

In the wake of recent mass layoffs at the U.S. Food and Drug Administration (“FDA”), the FDA is likely to have fewer resources to manage its regulatory responsibilities. One area that may be significantly impacted by such...more

Epstein Becker & Green

A Final Rule Bites the Dust: Federal Court Rules FDA Lacks Authority to Regulate LDTs

Epstein Becker & Green on

The order is in, and the LDT Final Rule is out. In May 2024, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published its Final Rule establishing its regulatory framework over laboratory developed tests...more

Haug Partners LLP

The Sole Meaning of “Solely”: Supreme Court Denies Certiorari on Edward Life Sciences v. Meril Life Sciences Pvt. Ltd. and Permits...

Haug Partners LLP on

This month the Supreme Court denied certiorari on Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., and in doing so, seemingly indicated its support for a broad interpretation of the Hatch-Waxman safe harbor...more

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

Federal Circuit: Patent Must Claim Active Ingredient for Orange Book Listing

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

On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. ...more

Ropes & Gray LLP

Stem Cell Litigation Update: FDA Won the Latest Battle, but the Future of HCT/P Enforcement Remains Unclear

Ropes & Gray LLP on

On September 27, 2024, the U.S. Court of Appeals for the Ninth Circuit reversed the district court’s decision in U.S. v. California Stem Cell Treatment Center, Inc. (“California Stem Cell”), holding that a clinic’s stem cell...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 210: Impacts of the Chevron Doctrine Ruling with Mark...

Maynard Nexsen on

This week, Heather and Matthew welcome their colleagues Mark Moore and Michael Parente, attorneys in Maynard Nexsen’s Government Investigations and White Collar Defense practice. We sit down to discuss their insights on the...more

Latham & Watkins LLP

New FDA Brief in Supreme Court Tobacco Case Puts Spotlight on Post-Chevron Regulatory Landscape

Latham & Watkins LLP on

FDA says its authority to implement the TCA is not limited by Loper Bright, but suggests that future guidance documents may be limited. On August 26, 2024, the US Food and Drug Administration (FDA or the Agency) filed its...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Spilman Thomas & Battle, PLLC on

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

Foley Hoag LLP

Loper Bright's Implications for the Food and Drug Administration and Regulated Industry

Foley Hoag LLP on

Under the Chevron doctrine, FDA and other agencies had significant flexibility to set policy where Congress left a gap or failed to speak clearly when enacting legislation—a common occurrence given the at-times sparse...more

Husch Blackwell LLP

The Overturning of Chevron Deference: Implications for AI in Medical Research

Husch Blackwell LLP on

In a landmark decision on June 28, 2024, the Supreme Court overturned a 40-year-old legal precedent known as Chevron deference. Established in 1984, Chevron deference mandated that judges defer to federal agencies concerning...more

Hogan Lovells

Chevron’s demise brings promises & perils for life sciences companies

Hogan Lovells on

The U.S. Supreme Court has issued its highly anticipated decision overturning the 40-year old doctrine established in Chevron v. Natural Resources Defense Council, which recognized judicial deference to administrative...more

Schwabe, Williamson & Wyatt PC

Chevron’s End Means Uncertainty and Opportunity for the Healthcare Industry

Schwabe, Williamson & Wyatt PC on

“Chevron is overruled.” The U.S. Supreme Court’s June 28 decision in Loper Bright Enterprises v. Raimondo and its companion case, Relentless v. Department of Commerce, will have enormous effects on the healthcare sector....more

Akin Gump Strauss Hauer & Feld LLP

Chevron Runs Out of Gas: The Bumpy Road Ahead for Health Regulations After Loper Bright

Akin Gump Strauss Hauer & Feld LLP on

On June 28, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the longstanding Chevron doctrine, under which courts generally granted deference to a federal agency’s reasonable interpretation of ambiguous...more

Morgan Lewis

Life Sciences Post-Chevron: Navigating the Range of Legal and Regulatory Challenges Raised by Loper Bright

Morgan Lewis on

The US Supreme Court’s decision in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce, which overrules the longstanding Chevron doctrine that required federal courts to defer to administrative...more

Foley Hoag LLP

Chevron’s Demise—And What It Means for Healthcare and Life Sciences Companies

Foley Hoag LLP on

Since 1984, the “Chevron doctrine” had served as the bedrock of many regulatory actions by the U.S. Department of Health and Human Services (HHS) and other federal agencies. Under the doctrine, courts followed a two-step...more

Proskauer - The Patent Playbook

Update on Artificial Intelligence: USPTO Urges Federal Circuit to Affirm Decision That AI Cannot Qualify as an “Inventor”

Proskauer - The Patent Playbook on

In three previous blog posts, we have discussed recent inventorship issues surrounding Artificial Intelligence (“AI”) and its implications for life sciences innovations – focusing specifically on scientist Stephen Thaler’s...more

Proskauer - Minding Your Business

Generic Competition for Withdrawn Drug Products

Proskauer - Minding Your Business on

When a pharmaceutical company withdraws a product from the market, the basis for the withdrawal can affect whether a competitor can commercialize a generic version of that product. A generic cannot be approved if, in the...more

Troutman Pepper Locke

Clinical Diagnosis of FDA's Clinical Investigation Exclusivity Standard? Unreasonable

Troutman Pepper Locke on

For drug innovators, particularly those focusing on repurposing drugs for new indications and developing drugs that are not considered new chemical entities, understanding the scope of the clinical investigation exclusivity...more

18 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