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FDA
Proposed FDA Guidance on Financial Disclosure and the Physician Payment…
(This article is adapted from a research paper written by Abraham Gitterman, Research Associate at Rockpointe who graduates magna…
FDA-CDER Solicits Comments on Issues in Product Development Including…
The Food and Drug Administration (FDA) announced earlier this year the establishment of a docket to receive suggestions,…
FDA: Enhancing Benefit-Risk Assessment in Regulatory Decision Making
Last summer, Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA), which included the fifth…
FDA Outlines Generic Safety and Efficacy
In a recent “Consumer Update,” FDA discussed what generic drugs are and how FDA ensures the safety and efficacy of alternatives to…
FDA Drug Shortages: Fundamental Problem is the Inability for the Market to…
A recent paper by FDA officials explored why and how manufacturing-quality problems could combine with other economic and…
FDA: Partnerships to Accelerate Medical Product Development
The Food and Drug Administration (FDA) recently gave a presentation on how the agency “Promotes Partnerships to Accelerate Medical…
Emerging Issues in Food and Drug Law: A National Conference for Lawyers,…
The University of Maryland Francis King Carey School of Law’s Law & Health Care Program and Student Health Law Organization…
FDA Reorganizing Office of Prescription Drug Promotion
Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) announced…
Court Upholds InterMune Executive Conviction on Misleading Speech
In December of last year, we reported on a landmark ruling from the United States Court of Appeals for the Second Circuit (New…
CME Programs to Reduce Opioid Abuse
Over the past several years, there has been significant attention drawn the prescription drug abuse and overuse of painkillers or…