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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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Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

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Canada Cuts Red Tape With Single Ethics Review For Trials

 
• By Neena Brizmohun

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 
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A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 
• By Eliza Slawther

The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.