Risk Assessment Standards From OMB Are Too Broad, FDA’s Galson Says
FDA is concerned that the White House Office of Management & Budget's definition of "risk assessment" outlined in its Proposed Risk Assessment Bulletin would constrain agency action by requiring too many analyses
You may also be interested in...
FDA's Drug Safety Oversight Board should start shifting its focus toward broader policy questions - like standards for boxed warnings - in addition to addressing emerging safety issues for specific products, DSOB Executive Director Susan Cummins suggested
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials