Key Insights for Pharma Manufacturers Regarding the AKS -
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more
4/29/2025
/ Abbreviated New Drug Application (ANDA) ,
Anti-Kickback Statute ,
Compliance ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements
It is not all doom and gloom for the cannabis industry this year; positive developments across states and the potential (albeit remote) for federal rescheduling means the cannabis industry can expect ongoing advancements....more
3/27/2025
/ Cannabis Products ,
Compliance ,
Controlled Substances Act ,
Corporate Transparency Act ,
Data Privacy ,
DEA ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Marijuana ,
New Legislation ,
New York ,
Popular ,
Proposition 65 ,
Regulatory Reform ,
Regulatory Requirements ,
State and Local Government
Last week, the US Food and Drug Administration (FDA) announced the end of a years-long shortage of semaglutide injection products — a popular glucagon-like peptide 1 (GLP-1) weight loss and diabetes medication. As a result,...more
2/27/2025
/ Compliance ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Pharmaceutical Industry ,
Pharmacies ,
Popular ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Requirements ,
Telehealth
In 2025, the retail and fashion industries are bracing for a transformative year, heavily influenced by the policies of the new Trump Administration. These policies promise rapid and significant changes, particularly in areas...more
2/20/2025
/ Americans with Disabilities Act (ADA) ,
Artificial Intelligence ,
CIPA ,
Class Action ,
Commercial Bankruptcy ,
Compliance ,
Data Privacy ,
E-Commerce ,
Environmental Social & Governance (ESG) ,
Executive Orders ,
Fashion Industry ,
Federal Trade Commission (FTC) ,
Form I-9 ,
Immigration ,
Independent Contractors ,
Influencers ,
International Trade ,
Mergers ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
NAD ,
PFAS ,
Private Attorneys General Act (PAGA) ,
Public Health ,
Retailers ,
Supply Chain ,
Tariffs ,
Terms of Use ,
Tracking Systems ,
Trump Administration ,
Workplace Investigations
As we have reported at length, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) imposed extensive new requirements related to cosmetic products marketed in the United States. As compliance deadlines for these new...more
6/24/2024
/ Compliance ,
Cosmetics ,
Fashion Industry ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
PFAS ,
Product Labels ,
Product Packaging ,
Product Recalls ,
Registration Requirement