Senior CDER Management Panel Could Facilitate Novel Therapy Approval
This article was originally published in The Pink Sheet Daily
CDER Director Janet Woodcock is creating an executive-level forum to deliberate medical policies, including those needed to smooth drug reviews. She envisions stakeholder input on topics for discussion by the panel.
You may also be interested in...
Sen. Bennet is receiving letters from patients asking to talk with FDA about products they think could be a breakthrough.
PhRMA and the Medical Information Working Group say the lack of clarity around FDAMA Sec. 114’s provisions governing dissemination of health care economic data to formulary committees warrants the medical policy council’s attention.
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.