RAPS

This Week at FDA: Agency allows Florida to import drugs; Biden turns to DPA to address drug shortages

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week ...

FDA declines to issue specific guidance on health programs' foreign drug imports

A CNBC investigation revealed the proliferation of AFPs, which import prescription drugs from overseas in what U.S.
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...
Medical Device and Diagnostic Industry (MD+DI)

User Fees Drive Most of the CDRH Increase in FDA’s Budget Request

FDA has released its budget request for fiscal year 2027, which would provide the agency’s Center for Devices and ...