Shared REMS: US FDA Wants Brisk Brand-Generic Talks, Might Give Unilateral Waivers
Executive Summary
New draft guidances are an attempt to curb abuse of REMS single shared system process to delay generic entry.
You may also be interested in...
REMS Abuse Website: Celgene, Actelion Top List Of Suspected 'Gamers'
Other sponsors could be using tactics other than REMS abuse to game the system, US FDA Commissioner Scott Gottlieb says.
REMS Website Will Name, Not Shame, Potential Abusers – Gottlieb
US FDA will list number of inquiries about acquiring samples for generic drug development, and also whether FDA sends letters to brand companies telling them it is safe to provide the generic sponsor with the samples.
Gottlieb: Real Risk Of Congressional Action If Anti-Competitive Actions Continue
To remain shielded from political forces that could change incentives, pharmaceutical industry must adopt 'a certain set of values,' US FDA Commissioner says.