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
Near the end of 2020, in mid-December, the Federal Trade Commission (FTC) launched what it referred to as “Operation CBDeceit,” a law enforcement sweep challenging allegedly unproven representations that CBD products could...more
VIDEO: Cryptocurrency - Legitimate Uses and Potential Issues - Following the recent publication of the U.S. Attorney General's cryptocurrency enforcement framework, Spilman attorneys Corey Bonasso and Nick Mooney discuss...more
COVID-19- Bipartisan Group of Attorneys General Seeks to Expand Production of Antiviral Drug- A bipartisan group of 34 AGs, led by California AG Xavier Becerra and Louisiana AG Jeff Landry, sent a letter urging the U.S....more
Labor & Employment- District of Columbia Attorney General Hits Two Employers for $500,000 over Alleged Wage Theft- District of Columbia AG Karl Racine reached a settlement with construction company Rock Spring Contracting,...more
Cannabis / Marijuana- FTC and FDA Issue Joint Warning Letter to CBD Retailer About Allegedly Unsubstantiated Health Claims- The Federal Trade Commission (“FTC”) and the Food and Drug Administration (“FDA”) issued a joint...more
Charities- 4 Attorneys General Settle with Military Charity Over Alleged Deceptive Practices- Four AGs, led by Virginia AG Mark Herring, reached a settlement with Hearts 2 Heroes Inc., d/b/a Active Duty Support Services...more
Antitrust- 33 Attorneys General, U.S. Department of Justice, FTC Settle With Pharmaceutical Manufacturer Over Allegedly Monopolizing Opioid Addiction Treatment Market- 33 AGs, the U.S. Department of Justice (“DOJ”), and...more
Antitrust- 10 Attorneys General Sue to Enjoin Merger of Major Wireless Phone Companies- 10 AGs, led by New York AG Letitia James and California AG Xavier Becerra, filed a lawsuit to enjoin T-Mobile US, Inc. and its parent...more
Cannabis / Marijuana- FTC and FDA Issue Warning Letters to Companies Advertising and Selling Cannabidiol Products- The Federal Trade Commission (“FTC”) and the Food & Drug Administration (“FDA”) issued warning letters to...more
Consumer Financial Protection Bureau- 25 Democratic Attorneys General Oppose CFPB Proposed Rule to Delay Compliance Date of Payday Lending Rule- 25 Democratic AGs, led by North Carolina AG Josh Stein, submitted a...more
Charities- Federal Trade Commission and Attorneys General of 50 States, DC, and US Territories Announce Coordinated Crackdown on Allegedly Fraudulent Veterans Charities- The Federal Trade Commission (“FTC”) and AGs...more
On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion. In his remarks, Deputy Assistant Attorney...more
In a two-page memorandum, the US Department of Justice (DOJ) announced a broad policy statement prohibiting the use of agency guidance documents as the basis for proving legal violations in civil enforcement actions,...more
On January 25, 2018, the Associate Attorney General directed the Department of Justice (DOJ) not to rely on agency guidance documents to establish a violation in affirmative civil enforcement (“ACE”) cases. She issued the...more
There are more than 165,000 mobile health applications available for download in Apple’s App Store or Google Play. This number will likely keep rising, and a body of federal and state regulators, including state attorneys...more
The New York Office of the Attorney General recently announced settlements with developers of three mobile health applications due to misleading claims and deficient privacy practices. As a result of these settlements, the...more
State Regulation - CWAG Talks Dietary Supplements - At a gathering of the Conference of Western Attorneys General, a panel on “Regulatory Models and Transparency” focused on enforcement against USPlabs as a case...more
Health app developers must be vigilant not only of federal laws, but of state laws as well. On March 23, New York Attorney General Eric T. Schneiderman announced a settlement with developers of three health-related...more
New York Attorney General Eric Schneiderman recently announced settlements with three mobile health app developers resolving allegations that they made deceptive advertisements and had irresponsible privacy practices. The...more
On March 23, 2017, the New York Attorney General’s office announced that it has settled with the developers of three mobile health (mHealth) applications (apps) for, among other things, alleged misleading commercial claims....more
New York Attorney General Eric T. Schneiderman announced on Friday that the AG's office reached settlements with three mobile application developers who marketed their apps without possessing sufficient information to back up...more
The Oregon AG recently announced a $545,000 settlement with the Vitamin Shoppe over allegations that the store violated Oregon state law by selling dietary supplements containing ingredients that FDA has deemed unsafe or...more
With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing practices that threaten (or those perceived as threatening) public...more
Lessons From the Frontlines: Strategies for Supporting Informed Consumer Decision-Making in the Health Insurance Marketplace - Editor's Note: As marketplaces prepare for the third open enrollment period, consumers are...more
The FDA provides oversight of dietary supplements. Recently, the New York Attorney General's Office sent cease and desist letters to four major national retailers accusing them of selling dietary supplements that failed to...more