Sequestration Day: FDA Will Manage For Now, But Could Suffer Later If Hiring Deferred
This article was originally published in The Pink Sheet Daily
Executive Summary
As the across-the-board cuts go into effect, not allowing FDA to add the hundreds of new employees that will be needed to meet the goals of user fee and other programs could damage the agency for years to come; NIH and CMS also will see significant effects.
You may also be interested in...
Would An NIH Grant Lottery Aide Funding Efforts?
Because it is now increasingly difficult to obtain an NIH grant, two scientists argue in a Wall Street Journal opinion article that the agency should determine grantees randomly instead.
Hamburg Details Some Sequestration Impact On FDA
Commissioner says allowing the sequester would slow implementation of FDASIA provisions and reduce some overseas inspections.
GDUFA Self-Identification Woes Can’t Deflate Industry, FDA Enthusiasm
As the grace period nears its close, industry officials say they expected problems getting generic drug manufacturing facilities to self-identify under the new user fee requirement; meanwhile, FDA expects to hire nearly three times the staff in the Office of Generic Drugs to meet GDUFA commitments.