US FDA Aims To Speed Communications On Cell And Gene Therapy Issues With Q&A Guidance
Advocates also call for reauthorization negotiations to be open to the public during meeting on the PDUFA VII commitment letter.
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BsUFA III Expands Biosimilar Supplement Review Goals To Speed Approvals
Six supplement categories based on submission content will be created with review goals between three and 10 months.
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.
GDUFA III Talks Completed; Fees will Fund Inspection, Complex Generic Improvements
Post-warning letter meetings for manufacturing issues and updates to the complex product meeting process are included in the user fee extension agreement.