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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
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
The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more
On Nov. 7, 2023, the Federal Trade Commission (FTC) announced it is disputing the listing of more than 100 patents in the Food and Drug Administration’s (FDA) “Approved Drug Products with Therapeutic Equivalence Evaluations,”...more
Key players across the healthcare industry—including sponsors, contract research organizations (CROs), research sites, regulators and patient advocates—are well aware of the challenges associated with the prompt and effective...more
On Wednesday, the Food and Drug Administration (FDA) released a new guidance document indicating that it will not enforce the medical evaluation and recordkeeping requirements (21 CFR §801.421(a) and (d)) prior to the...more
Tongue-in-cheek references to Pokémon Go as a health App aside, maybe the tech industry is on to something. In the U.S., seven out of every ten deaths are due to chronic diseases, such as diabetes or heart disease. Perhaps...more
Earlier this month, the U.S. Food and Drug Administration (FDA) announced a two day public hearing to take place November 9 and 10 aimed at obtaining input from industry to help shape FDA's policy regarding communications...more
Health care is always a major issue in Washington, DC but recently how to promote innovation in medtech has become a priority within that conversation. Thus far, 2015 has produced a major legislative initiative in the form of...more
Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate. In one of these...more
Personalized medicine has a friend in high places. President Obama recently announced an initiative to support “precision” or personalized medicine. In very general terms, the President stated during his 2015 State of the...more
The development and use of mobile technologies and devices is expanding at an incredibly fast pace and is changing, and in fact revolutionizing, the way patients and healthcare providers interact. Mobile medical technologies...more
The FDA will hold a public workshop on May 13-15, 2014 to discuss the long-awaited report (the “Report”) issued on April 3, 2014 by the three federal agencies charged with regulating health information technology (“health...more
Pepper Hamilton Health Care-Life Sciences Webinar - The explosion of mobile technology and Web applications linking patients with doctors, pharmacies and medical devices is undergoing scrutiny by the FDA, FTC, HHS and...more
I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no...more