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FDA
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…
FDA Centers for Drug Evaluation and Research: Project Quicker Approval…
This past summer, Congress passed and President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA)…
FDA Strategic Plan to Address Drug Shortages, Solicitation for Comment
Earlier this month, the Food and Drug Administration (FDA) released a notice for public comment in the Federal Register regarding…
HHS OIG Report: FDA Lacks Comprehensive Data to Determine Whether Risk…
The Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) released a report, which asserts…
PCORI News Plus FDA Suggestions on Comparative Effectiveness Research
The Board of Governors of the Patient-Centered Outcomes Research Institute (PCORI) at its 19 November 2012 meeting in Boston, MA…