Conflict Of Interest Reform: With FDA Undecided, Consumer Groups Give Their Pitch
FDA likes some rules in FDAAA and wants to continue discussion with Capitol Hill as changes are expected to be part of PDUFA legislation.
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CDER Advisory Panel Vacancies Remain High As Overall FDA Rates Improve
Empty slots on CDER advisory panels holding agency back from meeting goal vacancy rate as other centers fill more panel slots.
FDA Conflict Of Interest Screening Could Get Streamlined As Patient Involvement Increases
Agency is considering creating a pool of pre-screened patient representatives that would make it easier to place them in FDA-sponsored formal meetings and advisory committees.
Conflict of Interest Reform: Greatest Impact May Be Committee Vacancy Rate
FDA user fee reauthorization eliminates limits on waivers, which may ease the burden on FDA to fill open seats on its advisory committees. Vacancy rates have been as high as 24% in FY 2012.