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FDA
OMB Memo Outlines All FDA Guidance’s Will Be Reviewed by the White House…
The Trump administration recently issued new guidelines that will expand White House and congressional oversight and review of…
DTC Studies Shows Patients Next Step is to Research Their Own Conditions
As reported by Regulatory Focus, a new review of studies of direct-to-consumer (DTC) prescription drug advertising identifies…
HHS Finalizes Rule Requiring Manufacturers Disclose Drug Prices in TV Ads:…
On May 8, 2019, the Department of Health and Human Services (“HHS”) announced a final rule that will require direct-to-consumer…
FDA Funded Research Shows claim #1 Prescribed Has Value with Consumers
According to research funded by the FDA and published last month, participants in a study on direct-to-consumer (DTC) advertising…
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…