Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
The legal battle over the scope of orphan drug exclusivity continues, as the U.S. Food and Drug Administration (“FDA”) has recently lost a second case concerning the exclusivity provisions of the Orphan Drug Act (“ODA”)....more
In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court”) has vacated the Food and Drug Administration’s (“FDA”) 2024 final rule that sought to bring...more
On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory developed tests...more
Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more
Private equity investors in health care and life sciences must navigate a complex and shifting landscape influenced by regulatory and policy changes and technological advancements. As private equity investments in the health...more
I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more
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
On June 28, 2024, in Loper Bright Enterprises v. Raimondo, the US Supreme Court overruled the decades-old Chevron doctrine. This decision means that courts must now determine the meaning of federal statutes and effectively...more
Following a hotly contested election, Donald Trump is once again the president-elect and will return to the White House on January 20, 2025. He will do so with a dominant electoral college win, potentially a win of the...more
Cozen O'Connor will host Health Care & Life Sciences 2025, our annual in-person seminar exploring critical issues impacting health care and life sciences businesses. Join attorneys and professionals from our Health Care &...more
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
For nearly 40 years and in more than 18,000 judicial opinions, federal courts have used the Chevron doctrine to defer to an agency's reasonable interpretation of an ambiguous statute. On June 28, 2024, the U.S. Supreme Court...more
Welcome to Venable’s BiologicsHQ Monthly Injection – August 2024...more
Public companies should take note of several recent developments, including: ..Reversal of the Pegasystems trade secrets lawsuit that nevertheless preserves guidance to take care when describing litigation as “without...more
The recent Supreme Court decisions of SEC v. Jarkesy and Loper Bright Enterprises v. Raimondo have the potential to meaningfully impact the implementation and enforcement of the Drug Supply Chain Security Act (“DSCSA”) as...more
Life sciences companies are adding risk factor language in response to the U.S. Supreme Court overturning the Chevron Doctrine. As you may recall, the U.S. Supreme Court recently overturned the Chevron Doctrine....more
For nearly 40 years, federal courts have been required to defer to an agency’s interpretation of an ambiguous statute, even if the court did not agree with that interpretation. This deference, commonly referred to as Chevron...more
The Supreme Court’s decision in June 2024 in Loper Bright Enterprises v. Raimondo and Relentless Inc. v. Department of Commerce to overrule the Chevron doctrine has major implications for every administrative agency,...more
Welcome to our seventh 2024 issue of Decoded - our technology law insights e-newsletter. We have a few events we want to pass along to those interested in technology, but also other areas of law and business....more
Now that the dust has settled following the Supreme Court’s overhaul of administrative law through three late-term decisions, Akin litigators and policy advisors offer the most significant takeaways for businesses and...more
Methylene chloride, also known as dirchloromethane [osha.gov], is a volatile, colorless liquid with a chloroform like odor. Historically, it has been used in various industrial processes, such as pharmaceutical manufacturing,...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
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
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
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