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
Two years after the enactment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the US Food and Drug Administration (FDA) has published the long-awaited proposed rule on talc-containing cosmetics....more
In an industry known for its fast-paced changes, 2024 will be no different for cannabis. For all those with an eye on the industry, the number one question remains, is this the year for rescheduling? The answer is, maybe. And...more
4/19/2024
/ Artificial Intelligence ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Capital Raising ,
DEA ,
Decriminalization of Marijuana ,
FDIC ,
Hemp ,
Intellectual Property Protection ,
Machine Learning ,
Marijuana ,
Marijuana Related Businesses ,
Political Parties ,
Popular ,
Regulatory Agenda ,
Regulatory Requirements ,
State and Local Government ,
State Legislatures ,
Taxation ,
Trademarks
The United States Trademark Trial and Appeal Board (TTAB) recently affirmed a refusal to register a trademark for “hemp oil extracts” when used as an ingredient in dietary supplements, finding that the applicant could not...more