On February 20, 2025, U.S. Senators Dick Durbin (D-IL) and Roger Marshall, M.D. (R-KS) introduced bipartisan legislation, the Protecting Patients from Deceptive Drug Ads Act (the Act), which closes perceived “legal loopholes”...more
The U.S. Food and Drug Administration (FDA) began 2025 with a resolution to make food “healthy” again by announcing a trio of new final and proposed rules that are intended to make it easier for consumers to identify healthy...more
2/21/2025
/ Compliance ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
Product Packaging ,
Proposed Rules ,
Public Health ,
Regulatory Agenda ,
Regulatory Requirements
In the final days of the Biden administration, the Drug Enforcement Administration (DEA) released a proposed rule that would allow practitioners with a Special Registration to prescribe Schedule III-V, and in limited...more
1/22/2025
/ Compliance ,
Controlled Substances ,
Controlled Substances Act ,
DEA ,
Health Care Providers ,
Healthcare ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Requirements ,
Ryan Haight Act ,
Telemedicine
The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information...more
1/8/2025
/ Compliance ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Labeling ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements
Artificial intelligence (AI) has the power to revolutionize health care. In oncology, there are now opportunities to apply AI to support diagnostics, predictive analytics, and administrative functions.
This hot topic was...more
9/26/2024
/ Analytics ,
Artificial Intelligence ,
Best Practices ,
Compliance ,
Contract Terms ,
Due Diligence ,
Governance Standards ,
Health Care Providers ,
Healthcare ,
Information Security ,
Insurance Industry ,
Machine Learning ,
Medical Devices ,
Policies and Procedures ,
Popular ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Oversight ,
Reimbursements
In June 2023, the U.S. Food and Drug Administration (FDA) published final guidance (Guidance) on presenting risk and efficacy information for direct-to-consumer (DTC) promotional labeling and advertisements for prescription...more
9/12/2023
/ Advertising ,
Compliance ,
Direct to Consumer Sales ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Labeling ,
Marketing ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Risk Factors
Agility and resiliency remain essential attributes for manufacturers in 2023. Manufacturers are no longer focused on figuring out when things will return to “normal.”
Instead, they are applying lessons learned from the...more
7/11/2023
/ Artificial Intelligence ,
Best Practices ,
Clawbacks ,
Compensation ,
Compliance ,
Customs and Border Protection ,
Cyber Threats ,
Cybersecurity ,
Enforcement ,
Environmental Protection Agency (EPA) ,
Final Rules ,
Intellectual Property Protection ,
Machine Learning ,
Manufacturers ,
Securities and Exchange Commission (SEC) ,
Supply Chain
With Thanksgiving fast approaching, you have probably heard that there is a turkey shortage – brought about by a combination of rising costs for feed and fuel, continued labor shortages, and – if that were not enough –a...more
11/18/2022
/ Biden Administration ,
Compliance ,
Department of Justice (DOJ) ,
Disclosure Requirements ,
Enforcement ,
Executive Orders ,
Labor Shortage ,
Poultry ,
Proposed Rules ,
Sherman Act ,
Supply Chain ,
Supply Shortages ,
Unfair or Deceptive Trade Practices ,
USDA