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Advisory Committees Drug Review Regulation

Recent And Upcoming FDA Advisory Committee Meetings

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Executive Summary

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered. 

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Podcast: Diversity, Equity, and Inclusion Measures Continue to Evolve in the Clinical Space

Listen to expert perspectives from Tracey Parker, Vice President, Biometrics, Advanced Clinical and Rebecca Starkie, Senior Global Patient Engagement Director, Advanced Clinical on the recent history of DEI in clinical trials and the barriers to patient participation. Examine the key drivers that have influenced the development of diversity, equity, and inclusion programs for clinical trials.

Japan’s Theravalues Clinical Trial Claims Curcumin Benefits For Common Cold

Japanese curcumin specialist Theravalues claims to have found via a randomized clinical trial that its Theracurmin and Theracurmin Super dietary supplements can help alleviate some symptoms of the common cold. “However, the level of evidence is weak,” they warn. “Additionally, because the study was based on the reporting of subjective cold-like symptoms, it is was unclear whether the symptoms were actual subjective symptoms caused by an upper respiratory tract infection.”

Samsung Biologics Strikes $400m+ Biosimilars Supply Deal With Pfizer

Samsung Biologics has struck a deal worth over $400m to manufacture multiple biosimilars for Pfizer.

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Advisory Committees Drug Review Regulation
Latest Headlines

AstraZeneca/Sanofi’s Nirsevimab Nears US FDA Approval After Overwhelmingly Positive Adcomm

FDA’s Office Of Generic Drugs Gets New Permanent Director And Oversight Designee

Big Drug, Small Panel: US FDA Adcomm For Eisai/Biogen’s Leqembi Includes Only Six Voting Members

US FDA Balances Urgent Need For Platinum Chemotherapies Against Intas Plant’s Quality Failures

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