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FDA
REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is…
Recently the FDA issued final guidance on FDA’s application of the statutory factors in determining when a risk evaluation and…
FDA Outlines Plans for Medical Devices with AI
We frequently hear the buzz word “AI” (artificial intelligence), usually coupled with how it’s coming for our jobs and how…
FDA Defends Oversight of Generic Drugs
In response to reports questioning the FDA’s inspections and oversight of generic drugs, FDA Commissioner Scott Gottlieb and…
JAMA Article Outlines REMS Failure, Suggests Reforms
In a recent JAMA article, “Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release…
Gottlieb Announces Details of FDA Reorganization Plan
In one of his last remaining acts as Commissioner of the United States Food and Drug Administration (FDA), Scott Gottlieb laid out…
Is FDA Guidance on Biosimilars Unconstitutional?
Drug makers and trade groups have recently raised questions regarding a United States Food and Drug Administration (FDA) guidance…
Congress Seeks Information from FDA on Powerful Opioid
Drug pricing and opioids have remained front and center as the 116th Congress got sworn in and started hosting hearings and…
Ned Sharpless Appointed Acting FDA Commissioner
Scott Gottlieb, MD, Commissioner of the United States Food and Drug Administration (FDA), announced his resignation from his post…
21st Century Cures Act: Implementation Update
The Office of the National Coordinator for Health IT (ONC) has come under fire for what some consider a slow implementation of the…
Need a Prescription? There May Be an App for That…Soon
Smartphones have become ubiquitous today. Need a cab? There’s an app (or several) for that. Need to order groceries to be…