The SEC's Reach Beyond Publicly Traded Companies
#WorkforceWednesday®: NLRB’s Expanding Power - Pushback and Legal Challenges Ahead - Employment Law This Week®
NCAA Settlement Update — Highway to NIL Podcast
Consumer Finance Monitor Podcast Episode: The Demise of the Chevron Doctrine – Part II
#WorkforceWednesday: SEC Cracks Down on Private Companies for Violating Whistleblower Protections - Employment Law This Week®
Podcast: DOJ Goes After Civil Cyber-Fraud - Diagnosing Health Care
JONES DAY TALKS®: Consumer Protection Enforcement Changes Likely After SCOTUS AMG Decision
Jannica Houben and Katarzyna Golonka on Complex Investigations
Podcast: What's New for Insurers in Mental Health Parity Compliance - Diagnosing Health Care
Stephen Shaver on CARES Act Relief Funds and Healthcare Organizations
FERC: A Discussion on its Mission, Market Manipulation Investigations, and Common Violations
Nota Bene Episode 90: U.S. Q3 Check In: Stimulus, Relief, Election, and Direction with Elizabeth Frazee and Jonathan Meyer
Podcast: Non-binding Guidance: Examining FDA’s Enforcement Authority Over Stem Cell Clinics and Compounders
Podcast: Common Risks and Challenges in Running a Global Ethics & Compliance Program
FCPA Compliance and Ethics Report-Episode 167-Mara Senn on the Top 10 Practices in a Cross-Border Investigation
In early August, the U.S. District Court for the Northern District of Texas ruled that the civil money penalty (CMP) provision in the Food, Drug, and Cosmetic Act (FDCA) for tobacco products, 21 U.S.C. § 333(f)(9), is...more
ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more
ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more
For the last few years, we have been closely monitoring and reporting on COVID-19 related fraud enforcement efforts by federal agencies. We detailed those findings in our Health Care Enforcement 2020 Year in Review & 2021...more
On September 18, 2020, the U.S. Food and Drug Administration announced additional flexibility for manufacturers to comply with the agency’s updated Nutrition and Supplement Facts labeling requirements. Those requirements go...more
The U.S. Food and Drug Administration (FDA) extended the enforcement discretion period for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps) by an additional six months, citing the challenges...more
Although more and more pet owners are turning to CBD products to treat their pets, new action by the FDA is a stark reminder that those CBD pet products found on-line and in stores are considered illegal at the federal level....more
Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more
The Agency plays a significant role in the evolving legal landscape governing certain cannabis-derived products. Key Points: ..New law lifts or eases some, but not all, federal obstacles for certain cannabis-derived...more
The U.S. Food and Drug Administration (FDA) has issued Guidance detailing its intent to exercise enforcement discretion for the requirements of the Produce Safety rule as they apply to entities growing, harvesting, packing,...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
On July 6, 2016, the Eighth Circuit Court of Appeals issued its ruling in United States v. DeCoster, in which it upheld prison sentences for two executives under the “responsible corporate officer” (RCO) doctrine of...more
On Thursday, May 7, 2015, the FDA released draft guidance on the implementation of its mandatory recall authority. The guidance itself is not binding on food companies, but provides more information about the FDA’s recall...more