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Recent And Upcoming FDA Advisory Committee Meetings

Executive Summary

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

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Victoza’s Non-Cardio Safety May Dominate At FDA Panel Review

US FDA does not raise any major concerns about study’s design or results to support cardiovascular risk reduction claim for Novo Nordisk’s GLP-1 agonist liraglutide ahead of advisory committee, but agency gives close scrutiny to non-CV safety events of interest.

Biosimilars For Avastin, Herceptin To Cap Off Busy July For ODAC

Pfizer's Mylotarg attempt to return to US market is first up for FDA's Oncologic Drugs Advisory Committee, followed by Novartis's CAR-T therapy. ODAC will then give half-day review to Amgen's and Mylan's biosimilars, suggesting FDA is increasingly comfortable with the product category.

PCPC Working To Ensure State EPR Programs Are ‘Least Onerous As Possible’

The Personal Care Products Council is engaging on state legislation for extended producer responsibility programs, which impose the cost of recycling plastic materials on manufacturers. Emerging bills to prohibit use of the ‘chasing arrows’ recycling symbol on consumer packaging also have the trade group’s attention.

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