Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications -
On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more
On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more
5/1/2024
/ Compliance ,
Enforcement ,
False Statements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Labeling ,
Medical Devices ,
Misleading Statements ,
Premarket Approval Applications ,
Proposed Rules ,
Public Health
On August 2, 2021, the U.S. Food & Drug Administration (“FDA” or “the Agency”) published a final rule amending its medical product “intended use” regulations in an effort to provide direction and clarity to regulated industry...more
Effective March 22, 2021, USDA’s Final Rule Sets Forth Regime for Producing Hemp Products in the United States, Superseding Interim Rule -
On January 9, 2021, the U.S. Department of Agriculture (USDA) issued a final rule...more
2/3/2021
/ Biden Administration ,
Cannabidiol (CBD) oil ,
Corrective Actions ,
DEA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Hemp ,
Hemp Cultivation ,
Notice of Violation ,
USDA
On September 24, 2020, FDA announced that it was taking action to help lower prescription drug prices by issuing a final rule and a final guidance aimed at facilitating the safe importation of certain prescription drugs....more
10/5/2020
/ Canada ,
Department of Health and Human Services (HHS) ,
DSCSA ,
Executive Orders ,
Final Guidance ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Hospitals ,
Pharmacies ,
Pharmacist ,
Prescription Drugs
Yesterday, FDA published a proposed rule amending its medical product “intended use” regulations in an effort to “provide direction and clarity to regulated industry and other stakeholders.” If finalized, the rule would amend...more
The Final Rule Requires Manufacturers to Disclose List Prices of Prescription Drugs and Biological Products in Television Advertisements -
On May 8, 2019, the U.S. Department of Health and Human Services (HHS or the...more
5/14/2019
/ Administrative Authority ,
Advertising ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Disclosure Requirements ,
Drug Pricing ,
Final Rules ,
First Amendment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency