Historical Drug Disasters (Thalidomide and Vioxx), Issues With Drug Studies, and Approvals and

Описание: Historical Drug Disasters (Thalidomide and Vioxx), Issues With Drug Studies, and Approvals and Challenges in Ensuring Drug Safety - Mary J Ruwart, Ph.D

Mary J. Ruwart, Ph.D., explores the unintended consequences of pharmaceutical regulations, highlighting how amendments have inadvertently stunted small pharmaceutical companies' growth and hindered drug innovation. She emphasizes the burden these regulations place on smaller companies, leading to a decline in new drug production and an increase in company mergers. Ruwart suggests this regulatory framework may not necessarily make drugs safer, noting that post-amendment drug withdrawals increased. The lecture examines these complex issues, providing insights into the pharmaceutical industry's challenges and potential paths forward for improving drug safety and innovation. #PharmaceuticalRegulation #DrugSafety #InnovationBarrier

00:00 Emergence of Big Pharma and Reduction of Small Firms
01:45 Merging of Companies and FDA Approval Process
02:56 Small Companies Licensing Drugs to Big Pharma
03:52 Drug Safety and Withdrawals
04:52 Historical Drug Disasters (Thalidomide and Vioxx)
06:22 Challenges in Ensuring Drug Safety
08:01 Issues with Drug Studies and Approvals

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