In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more
1/31/2025
/ Artificial Intelligence ,
Biden Administration ,
Data Management ,
Digital Health ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Management ,
Transparency
The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more
1/22/2025
/ Administrative Procedure Act ,
Consent Decrees ,
Constitutional Challenges ,
Corporate Integrity Agreement ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Safety ,
Life Sciences ,
Medical Devices ,
Opioid ,
OxyContin ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Purdue Pharma ,
Qui Tam ,
Regulatory Requirements ,
Stem cells ,
Transparency
In recent years, Congress and the U.S. Food and Drug Administration (“FDA”) have sought to reform the accelerated approval process, an expedited development and approval pathway for drugs that provide meaningful therapeutic...more
1/22/2025
/ Clinical Trials ,
Draft Guidance ,
Drug Safety ,
FDA Approval ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Regulatory Requirements
On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more
1/14/2025
/ Advertising ,
Compliance ,
Enforcement Actions ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Marketing ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements