I. Key Takeaways -
- The Secretary of Commerce is investigating the effects of imports of pharmaceuticals and pharmaceutical ingredients (and their derivative products) on national security to support potential tariffs or...more
4/18/2025
/ Biologics ,
Comment Period ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Imports ,
Medical Devices ,
National Security ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain ,
Tariffs ,
Trade Expansion Act of 1962 ,
Trade Relations ,
U.S. Commerce Department
On January 6, 2025, FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” This...more
Health providers and consumers increasingly rely on the internet for health and medical-related information, but not all such information is reliable, and many statements are downright false. The proliferation of social media...more
7/15/2024
/ Draft Guidance ,
Enforcement ,
False Statements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Internet ,
Medical Devices ,
Pharmaceutical Industry ,
PHSA ,
Policy Statement ,
Prescription Drugs ,
Regulatory Reform
On June 26, 2024, FDA issued a new draft guidance on clinical trial diversity, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (Draft Guidance), to assist...more
On December 26, 2023, the Food and Drug Administration (FDA) released a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a...more
On October 30, 2023, President Biden issued an executive order (EO) to guide federal agencies on the development and use of artificial intelligence (AI). The administration views AI as holding numerous benefits but at the...more
10/31/2023
/ Artificial Intelligence ,
Biden Administration ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Pharmaceutical Industry ,
Prescription Drugs ,
Technology Sector ,
Telemedicine
After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more
On June 27, 2023, the Food and Drug Administration’s ("FDA") Office of Prescription Drug Promotion ("OPDP") published a final guidance (the "Final Guidance") on Presenting Quantitative Efficacy and Risk Information in...more
7/11/2023
/ Advertising ,
Direct to Consumer Sales ,
Final Guidance ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Labeling ,
Marketing ,
OPDP ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs
Key Takeaways:
▪️ FDA has published a proposed rule proposing national licensing standards for prescription drug wholesale distributors and third-party logistics providers as well as standards for third-party accreditation...more
2/14/2022
/ Drug Distribution ,
Drug Wholesaling ,
Food and Drug Administration (FDA) ,
Licensing Rules ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Standards ,
Supply Chain ,
Third-Party