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FDA
OPDP Sends Third Untitled Letter of the Year to Eton Pharmaceuticals
On August 9, 2021, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent its…
FDA Reconsidering the Need for Mandatory Opioid Prescriber Education
Recently, the United States Food and Drug Administration (FDA) announced a public workshop to discuss mandatory prescriber…
Woodcock Calls for HHS OIG Investigation Into Aduhelm Approval
After the controversial FDA approval of Aduhelm, Biogen’s Alzheimer’s disease therapy, the agency’s acting commissioner is calling…
FDA Finalizes Guidance on Field Alert Report Submissions
In late July 2021, the United States Food and Drug Administration (FDA) finalized guidance on expectations for field alert reports…
Amgen Receives Untitled Letter for Banner Ad Promoting Neulasta
The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) recently sent an untitled letter…
FDA Releases Draft Guidance on Sponsor Safety Reporting Requirements
Earlier this summer, the United States Food and Drug Administration (FDA) released updated draft guidance for sponsors on safety…
OPDP To Study Promotion of Prescription Drugs at HCP Conferences
In mid-July 2021, the United States Food and Drug Administration (FDA) published a proposed collection of information in the…
FDA Approves New Alzheimer’s Drug
On June 7, FDA approved Aduhelm (aducanumab) to treat patients with Alzheimer’s disease using the Accelerated Approval pathway,…
HHS and FDA Withdraw UDI Termination Notice
On November 20, 2020, the U.S. Department of Health and Human Services (HHS) had announced that the Department was terminating the…
FDA Issues Notice of Noncompliance for Failure to Submit Clinical Trial…
On April 27, 2021, the United States Food and Drug Administration (FDA) issued its very first Notice of Noncompliance for failure…