On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more
7/17/2025
/ Compliance ,
Disclosure Requirements ,
Drug Pricing ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agencies ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management ,
Transparency
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