1. Pink Sheet

Gottlieb Issues Statement On Adverse Event Limitations – An Attempt To Quell Fears?

 
• By Michael Cipriano

Commissioner Scott Gottlieb's statement noting the limitations of FAERS comes just four days after he was quoted in an FDA announcement about the launch of a more searchable portal for the adverse event database.

Drugs Pills In Wooden Box

US FDA Commissioner Scott Gottlieb outlined the limitations of data from FDA's Adverse Event Reporting System (FAERS) in what may be an attempt to tamp down reactions to media and analyst reports on adverse events.

In an Oct. 2 statement, Gottlieb stressed that data associated with a particular drug or biologic do not necessarily mean the product is the cause of the adverse event. "Importantly,...

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• By Francesca Bruce

Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.

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• By Neena Brizmohun

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