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FDA
FDA Office of Compliance Issues Annual Report
Recently, the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Compliance…
FDA Launches Educational Initiative About Supplements
On June 2, 2022, the United States Food and Drug Administration (FDA) announced a new initiative, Supplement Your Knowledge. The…
Policy and Medicine Compliance Update – June 2022 Issue: Explores Role of…
Policy and Medicine Compliance Update is our monthly compliance publication designed to help compliance professionals go in depth…
OPDP to Study Product Claims in DTC and HCP Promotions
Earlier this year, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) published a…
FDA Issues Notice of Proposed Collection of Information
On April 25, 2022, the United States Food and Drug Administration (FDA) published a Notice in the Federal Register, indicating its…
FDA Issues Draft Guidance Focused on Clinical Trial Diversity
The US Food and Drug Administration is recommending sponsors include a plan to increase diversity when proposing clinical trial…
Bausch Health Receives Untitled Letter from OPDP Over Statements Made on…
On March 31, 2022, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent an…
McKinsey – Serving as a Double Agent?
In April 2022, the United States House of Representatives’ Committee on Oversight and Reform issued a report, finding that 22…
COVID Didn’t Seem to Slow Down FDA Drug Approvals
While COVID-19 has impacted almost every facet of our lives over the last few years, one area that it didn’t seem to have a huge…
Budget Increase for the FDA in 2023?
In March 2022, United States President Joe Biden released his budget request for Fiscal Year 2023, which included a significant…