Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Sentinel Could Be Used For Pregnancy Safety Studies Under PDUFA VII

Executive Summary

User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.

You may also be interested in...



US FDA Drug Review Goals Should Be Faster In PDUFA VII, Industry Negotiators Propose

Sponsor representatives also want postmarketing discussions moved to earlier in the assessment cycle.

US FDA Hiring Metrics Sought To Determine PDUFA VII Changes

Other subgroups negotiating specific issues for the user fee reauthorization have indicated that agreements are close.

CBER Proposes Increasing Cell, Gene Therapy Staff In PDUFA VII

'Indirect and direct review roles' would be added with user fee funds after the PDUFA program is reauthorized.

Related Content

Topics

UsernamePublicRestriction

Register

PS143637

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel