CDER Vs. CBER: Consulting As Usual, Or Hints Of Inter-Center Power Struggle?
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
In the Provenge review documents FDA has released so far, there is little indication of overt struggle between the drugs and biologics camps - but many signs that the overheated public and media atmosphere was making the agency especially careful in its dealings with the sponsor.
You may also be interested in...
US FDA’s Most Controversial Drug Approval Decisions, From A To Z
Following accelerated approval of Biogen’s Alzheimer’s drug aducanumab in the US, we look back at 10 of the FDA’s most controversial drug approval decisions, from Addyi to Zohydro.
US FDA’s Most Controversial Drug Approval Decisions, From A To Z
With action imminent on Biogen’s Alzheimer’s drug aducanumab, the Pink Sheet looks back at 10 of FDA’s most controversial drug approval decisions, from Addyi to Zohydro.
Provenge Panel's Uncertainty Was More Persuasive To FDA Than Its Vote
FDA found the uncertainty expressed by the advisory committee reviewing Dendreon’s Provenge to be a better guide for regulatory action than the panel’s numerical vote supporting approval, according to the FDA review documents for the first autologous cancer vaccine.