FDA Needs More Resources, Good Leadership, Daschle Tells Senate Panel
This article was originally published in The Gray Sheet
Executive Summary
At a Jan. 8 confirmation hearing before the Senate Health, Education, Labor and Pensions Committee, HHS Secretary nominee Tom Daschle said that FDA needs more resources, better public policy and stronger leadership if it is to improve the device and drug approval processes and worker morale
You may also be interested in...
ODE Chief Tillman Defends 510(k) Program At Minnesota Industry Meeting
FDA's head of device evaluation is defending the agency's handling of 510(k) pre-market notification submissions in the face of criticism from two groups: those who charge the agency has allowed devices on the market without sufficient scientific evidence, and industry representatives who claim that FDA often demands too much from 510(k) applicants
“Ordered, Intimidated And Coerced”? CDRH Targeted In Misconduct Probe
FDA's device center has until Dec. 1 to respond to a Congressional inquiry into allegations of wrongdoing in its pre-market review process
iPLEDGE REMS: FDA Panel To Consider Changing Pregnancy Testing, Counseling Requirements
Advisory committee to discuss proposed changes to isotretinoin REMS to minimize burden and treatment delays while preventing risk of fetal exposure. Agency recommends against at-home pregnancy tests.