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
In a concerted effort to combat the illegal sale of delta-8 THC edibles packaged to look like popular snacks, the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have recently begun issuing...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more
When it comes to mitigating the risk of class action lawsuits, the best offense is a good defense. Companies can take many steps to reduce their exposure to class action litigation before it happens, including the tactics...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
For years, the antitrust enforcement agencies have indicated their antipathy toward resolving competition issues in proposed mergers by entering into consent decrees that prohibit certain conduct, rather than stopping the...more
This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...more
For the first time ever, the Federal Trade Commission (FTC) is seeking enforcement under the Health Breach Notification Rule. This regulation requires certain businesses not covered by the Health Insurance Portability and...more
In December 2022, the the Federal Trade Commission published new guidance regarding representations about the benefits and safety of health-related products: Health Products Compliance Guidance. Federal Trade Commission...more
FDA warning letters are nothing new in the cannabis industry. In fact, we here at Budding Trends have covered this topic a number of times (here, here, and here). Not resigned to playing the hits, however, the FDA issued a...more
As the COVID-19 public health emergency drags into its third year, we continue to keep track of efforts by the Food and Drug Administration (FDA) to combat fraud in the form of fake cures, counterfeit diagnostic tests, and...more
In a unanimous decision in AMG Capital Management, LLC v. FTC, the U.S. Supreme Court held that the Federal Trade Commission (FTC) lacks authority under Section 13(b) of the FTC Act to seek restitution or disgorgement. The...more
While gearing up to get trillions of dollars into the economy, the government was also setting in place the mechanism to investigate and prosecute fraud related to these programs. The CARES Act was signed into law on March...more
Agency Notice Touts Authority to Regulate Products Containing Cannabis and Cannabis-derived Compounds - On April 4, 2019, the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register that it...more
Happy New Year! And now on to your regular Consumer Product Matters programming… Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement...more
Advertising and marketing laws affect all businesses that expose consumers to their goods and services. In 2016, highlights of advertising and marketing law issues included disclosures and celebrity endorsements, “Made in...more
We reported a few weeks ago about a new warning from FDA related to the safety of certain teething-related, non-prescription homeopathic drug products, and in that post we mentioned that both FDA and the Federal Trade...more
The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices. In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more
In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more