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
On July 30, 2025, the U.S. Department of Justice (DOJ) announced that biotechnology company Illumina Inc. agreed to pay $9.8 million plus interest to resolve allegations of misrepresenting compliance with federal...more
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
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
TSCA/FIFRA/TRI - EPA Issues Asbestos Part 2 Draft Risk Evaluation, Preliminarily Determines That Asbestos Poses Unreasonable Risk To Human Health: On April 16, 2024, the U.S. Environmental Protection Agency (EPA) announced...more
Key Points: Illumina DNA sequencing machines are vulnerable to exploitation. Both the Cybersecurity and Infrastructure Security Agency (CISA) and the Food and Drug Administration (FDA) have published advisories urging all...more
A district court in Utah recently dismissed claims brought against a biotechnology company and its officers under Section 10(b) of the Securities Exchange Act and Rule 10b-5 adopted thereunder. The order in Richfield v....more
TSCA/FIFRA/TRI - ARTICLE -- Lynn L. Bergeson And Richard E. Engler, Ph.D. Author “Optimizing The Toxic Substances Control Act To Achieve Greener Chemicals,” For ABA’s NR&E Magazine: TSCA offers tremendous unrealized...more
The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more
TSCA/FIFRA/TRI - “Environmental Justice: Operationalizing TSCA to Fulfill Its Destiny,” By Lynn L. Bergeson For The American College Of Environmental Lawyers (ACOEL) Blog: The Biden Administration has embraced environmental...more
September 17, 2020 Update: The Trump administration is currently considering accelerating the approval of an experimental Covid-19 vaccine being developed by Oxford University and AstraZeneca. In line with FDA’s June 2020...more
TSCA/FIFRA/TRI - Lynn L. Bergeson, “Feeling The Pinch: Who Pays TSCA Risk Evaluation Fees?,” Financier Worldwide, September 2020: Ordinarily, government fees command little interest in corporate finance and board-level...more
Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more
TSCA/FIFRA/TRI - EPA Seeks Comment On Manufacturer Requests For Risk Evaluation Of DIDP And DINP: On August 19, 2019, the U.S. Environmental Protection Agency (EPA) announced that it seeks comment on manufacturer requests...more
In response to concerns expressed by livestock groups and some in the biotechnology industry over the Food and Drug Administration's (FDA's) approval process for gene editing in animals, the Trump administration issued an...more
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
On October 30, 2018, the U.S. Food and Drug Administration “announced the Plant and Animal Biotechnology Innovation Action Plan to outline the key priorities the agency will pursue to support innovation in plant and animal...more
TSCA/FIFRA/TRI - EPA Releases Budget Justification That Increases Budget For Chemical Risk, Review, And Reduction Program: On March 11, 2019, EPA released its Fiscal Year (FY) 2020 Justification of Appropriation Estimates...more
2018 Filings - Companies in the life sciences industry, including biotechnology, medical devices, and pharmaceuticals, have long been favorite targets of securities class actions, and 2018 was no exception. According to a...more
TSCA/FIFRA/TRI - EPA Proposes Joint Stipulation In Ellis Case Requiring EPA To Issue ESA Effects Determinations For Two Neonicotinoid Pesticides: On December 12, 2018, EPA announced a proposed joint stipulation and proposed...more
TSCA/FIFRA/TRI - EPA Issues Final TSCA Fees Rule: On October 17, 2018, EPA issued a final fees rule under TSCA. 83 Fed. Reg. 52694. The final rule largely tracks the proposed rule....more
TSCA/FIFRA/TRI - EPA To Host Best Practices For Ground Application Webinar: On September 20, 2018, EPA announced it would be hosting a webinar titled “Best Practices for Ground Application” on October 25, 2018, from 2:00...more
TSCA/FIFRA/TRI - EPA Issues Two Direct Final Rules Promulgating SNURs For 29 Chemicals: On August 27, 2018, EPA issued two direct final rules promulgating significant new use rules (SNUR) under TSCA. The first direct final...more
TSCA/FIFRA/TRI - EPA’s Spring 2018 Unified Agenda And Regulatory Plan Released: On May 9, 2018, the Office of Information and Regulatory Affairs (OIRA) posted the spring 2018 Unified Agenda and Regulatory Plan. OIRA states...more
Overview: - Since enactment on June 22, 2016, of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA has implemented a muscular regulatory program expressing Congress’ intent for a new and improved Toxic...more
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more