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
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
The biotechnology and life science sectors underpin breakthroughs in health care, agriculture, and environmental sustainability by leveraging living systems to create next-generation medicines, diagnostics, and bio-based...more
With volatile market conditions and recent FDA shakeups, biotech companies are increasingly focused on bolstering cash runways and accelerating R&D efforts. But fierce competition for financing has some biotechs turning to...more
The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries. Cybersecurity & Privacy - The Monthly Rundown of All Things Cyber, Privacy,...more
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
In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA....more
On June 3, 2025, lawmakers introduced the Supporting Accessible, Flexible, and Effective (SAFE) Sunscreen Standards Act in the U.S. House of Representatives, aiming to bring U.S. sunscreen regulations in line with scientific...more
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
Since the publication of our article on what to expect for stem cell regulation under the new administration, we’ve been closely monitoring the administration’s enhanced focus on the same....more
Blank Rome presents a new summer webinar series where our interdisciplinary team will unpack the most pressing legal, regulatory, and policy developments from the Trump Administration’s first 180 days. Each session offers...more
On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more
The $100B+ Weight-Loss Drug Market Is Red Hot—But So Are the Legal, Regulatory, and Compliance Risks. As the GLP-1 revolution reshapes the future of metabolic health, life sciences companies face mounting scrutiny from...more
On June 17, 2025, the Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a bold initiative designed to accelerate the review of therapies addressing critical national...more
On June 17, the Food and Drug Administration announced the establishment of the Commissioner's National Priority Voucher (CNPV) program. Although initial details are sparse, the CNPV promises fast action, allowing drug...more
The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent months combined with market...more
Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more
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
On April 30, the US Food and Drug Administration (FDA), approved the use of a gene-edited pig to confer resistance to Porcine Reproductive and Respiratory Syndrome (PRRS), a devastating swine disease....more
The Trump Administration released its Make Our Children Healthy Again Assessment on May 22, 2025, documenting its rationale for future policy actions related to chronic disease in children. The report focuses on four key...more
As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and document backlogs to operational restructuring. While core review functions are still running, early...more
On May 22, 2025, the FDA approved Bio-Thera Solutions and Hikma Pharmaceuticals’ ustekinumab biosimilar, STARJEMZA® (ustekinumab-hmny) injection, referencing Janssen’s STELARA® (ustekinumab) injection....more
The FDA is moving quickly to bring artificial intelligence (AI) into the heart of its regulatory review process. On May 8, 2025, the agency announced the successful completion of its first AI-assisted scientific review—and...more
Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more
In their song, “Surprise, Surprise,” the Rolling Stones lamented about being caught off guard by a disappointing relationship. Sixty years later, foreign manufacturers may face the surprise of an unannounced inspection by the...more
Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...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