A PDUFA First: Pre-Approval Inspection Notice Goal Will Be Created
Under new user fee agreement, sponsors will get at least 60-day notice when a pre-approval inspection is necessary; regulators and manufacturers hope increased communications will lead to more efficient reviews.
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Advocates also call for reauthorization negotiations to be open to the public during meeting on the PDUFA VII commitment letter.
Head of Office of New Drugs highlights programs being established under PDUFA VII that could help overcome obstacles in drug development.
If they reach a public disclosure agreement, a handful of sponsors will be admitted to a new pilot program that allows four meetings with the FDA on rare disease endpoint issues.