Inside FDA’s Debates On ‘Breakthrough’
Executive Summary
Office of New Drugs Director Jenkins provides a peek into the Medical Policy Council’s efforts to consistently interpret and implement the ‘breakthrough therapy’ program.
You may also be interested in...
US FDA Hoping To Solve Drug-Software Issues With Digital Health Working Group
As more applications include software components, group wants assessors to apply best practices from CDRH to CDER whenever possible.
CDER Medical Policy Council Balances “Breakthrough” Requests With Broader Issues
FDA is seeking public input on cross-cutting policy issues to bring before the senior-level group, which is also facing the challenge of reviewing dozens of “breakthrough therapy” designation requests relevant to CDER-regulated products.
Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing
Commissioner Robert Califf discussed the agency’s request for $12.3m to address shortages and legislation to require that manufacturers provide more detailed information about increased demand and supply chain vulnerabilities.