CDER “Equal Voice” Policy Does Not Mean Equal Weight In Decision-Making
The Center for Drug Evaluation and Research’s new internal guidelines implementing the “Equal Voice” initiative suggest each scientific discipline’s perspective will be given equal time, but not equal weight.
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Operation Warp Speed For Rare Diseases? US FDA Is Considering Pilot Programs
CBER director Peter Marks says the FDA may evaluate giving gene therapy products the ‘degree of responsiveness’ that COVID-19 vaccines received. In a discussion of the pandemic's effects on staff retention, CDER director Patrizia Cavazzoni says attrition rates are back to historical levels.
Rx Safety: FDA Needs Deadline - Not Funding - To Improve Process, GAO Says
GAO is not buying an FDA assertion that the delay in giving the Office of Surveillance and Epidemiology more responsibility for post-market drug safety decisions is a funding issue
FDA Drug Review, Surveillance Offices Agree To Share Safety Authority
FDA's drug review and drug safety offices have set aside their differences and laid out an agreement that more equally divides regulatory authority on issues related to drug safety