CDER Policy Council Urged To Address Manufacturer/Payer Communications
Executive Summary
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.
You may also be interested in...
FDA Promises More Off-label Guidances As Part Of First Amendment Harmonization
Agency grants two citizen petitions from a coalition of pharma companies requesting greater clarity from FDA, but whether the forthcoming guidances will satisfy industry remains an open question.
Senior CDER Management Panel Could Facilitate Novel Therapy Approval
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.
Off-Label Use Discussions Should Stay Off-line, FDA Draft Guidance Says
FDA advises companies to respond to unsolicited requests for off-label information in one-on-one dialogue; the agency also requests public comments on its policies regarding off-label communications in response to an industry citizen petition.