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FDA
FDA Issues Draft Guidance Focused on Clinical Trial Diversity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…
FDA Finalizes Guidance to Help Regulated Industries with Voluntary Recalls
In early March 2022, the United States Food and Drug Administration (FDA) finalized guidance to help regulated industries (i.e.,…
FDA Requests Comments on Potential Modification to Opioid Analgesic Risk…
On April 21, 2022, the United States Food and Drug Administration (FDA) filed a Notice and Request for Comment regarding a…
FDA Publishes Guidance on Premarket Pathways for Combination Products
Earlier this year, the United States Food and Drug Administration (FDA) published a final guidance, “Principles of Premarket…
FDA Announces Proposed Recommendations for Fifth Reauthorization of Medical…
On March 22, 2022, the United States Food and Drug Administration (FDA) announced that the agency had reached an agreement with…
FDA Plans to Move Forward with Studies on Patient Understanding of…
In June 2021, the United States Food and Drug Administration (FDA) published a 60-day notice requesting public comment on the…