Moving marijuana under the Controlled Substances Act (“CSA”) from Schedule I to Schedule III will bring celebrated changes to the beleaguered state-sanctioned cannabis industries currently operating in 37 states, but will...more
5/30/2024
/ Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Farm Bill ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Internal Revenue Code (IRC) ,
Marijuana ,
Motion To Reschedule ,
Notice of Proposed Rulemaking (NOPR) ,
Proposed Rules ,
Tax Deductions
The Federal Trade Commission’s (FTC) recent press release marks a continuation in government action against manufacturers of products infused with delta-8 tetrahydrocannabinol (delta-8). In May 2022, the U.S. Food and Drug...more
On March 9, 2023, the Food and Drug Administration (FDA) published a final rule that updates the Mammography Quality Standards Act (MQSA) to reflect advances in mammography technology and, among other requirements,...more
A spurt of letters from California Attorney General Rob Bonta to leaders of hospitals and other health care facilities sent on August 31, 2022 signaled the kickoff of a government probe into bias in health care algorithms...more
9/13/2022
/ Algorithms ,
Artificial Intelligence ,
California ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Costs ,
Hospitals ,
Machine Learning ,
Non-Discrimination Rules ,
Software ,
State Attorneys General
On May 4, 2022, the U.S. Food and Drug Administration (FDA) for the first time issued warning letters related to products containing delta-8 tetrahydrocannabinol (delta-8 THC). FDA has previously sent warning letters to...more
On January 12, 2022, the co-owner of a clinical research site in Miami, Florida pleaded guilty to one count of obstruction of justice after she knowingly lied to a United States Food and Drug Administration (FDA) investigator...more
The U.S. Food and Drug Administration (FDA), industry, policymakers, and consumers share a common goal of ensuring that the foods and beverages Americans eat and drink are safe, and the law has long prohibited the...more
In an unexpected twist to a troubling situation that began over two years ago, U.S. Special Counsel Henry Kerner penned a letter to President Biden on March 31, 2021 questioning the Food and Drug Administration’s (FDA’s)...more
The Office of Inspector General for the U.S. Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Requestor) to provide financial...more
2/3/2020
/ Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
CMP Law ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
REMS ,
Travel Expenses