FDA Handling Of Antidepressant Inquiry “Troubles” Senate Investigators
This article was originally published in The Pink Sheet Daily
Executive Summary
Finance Committee staff continues its inquiry into how FDA handled information on a possible link between antidepressants and suicidality. A June 2 letter asks for contact information of former Office of Drug Safety employees and a list of meetings between CDER officials and manufacturers.
You may also be interested in...
FDA Office Of Drug Safety “Separate But Unequal” To Office Of New Drugs, Senate Inquiry Finds
Finance Committee Chairman Grassley’s investigation into FDA’s handling of pediatric suicidality concerns with antidepressant drugs reveals ODS “serves a subservient” role to OND. Grassley points to allegations that OND discourages recommendations in drug consults.
FDA Office Of Drug Safety “Separate But Unequal” To Office Of New Drugs, Senate Inquiry Finds
Finance Committee Chairman Grassley’s investigation into FDA’s handling of pediatric suicidality concerns with antidepressant drugs reveals ODS “serves a subservient” role to OND. Grassley points to allegations that OND discourages recommendations in drug consults.
Paxil Fraud Case May Spur Congressional, FDA Action – Schering Exec
Pressure is growing for greater disclosure of study results, which may shift industry R&D, Schering compliance VP Saunders says. Former DoJ attorney Bentivoglio suggests that disclosure requirements would include cost-effectiveness data.