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/ Draft Guidance ,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On June 26, 2024, FDA issued a new draft guidance on clinical trial diversity, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (Draft Guidance), to assist...more
On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more
10/25/2023
/ Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Labeling ,
Medical Devices ,
Medical Software ,
Pharmaceutical Industry ,
Policies and Procedures ,
Regulatory Requirements ,
Regulatory Standards
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Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more
Key Takeaways:
The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials.
FDA’s recommendations come as part of increasing interest in ensuring clinical...more
4/20/2022
/ Abbreviated New Drug Application (ANDA) ,
Biden Administration ,
Biologics ,
Black and Minority Ethnic (BME) ,
Clinical Trials ,
Corporate Counsel ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Diversity ,
Draft Guidance ,
FDASIA ,
Food and Drug Administration (FDA) ,
Investigational New Drug Application (IND) ,
Licenses ,
National Institute of Health (NIH) ,
Premarket Approval Applications ,
Sponsors