Pink Sheet is part of the Informa Intelligence Division 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

FDA/industry user fee II proposal would cut review deadline to 10 months from current 12.

This article was originally published in The Tan Sheet

Executive Summary

FDA/INDUSTRY USER FEE II PROPOSAL WOULD CUT NDA REVIEW DEADLINE BY TWO MONTHS, from 12 to 10 months, for standard NDAs and biological licensing applications. Under a user fee reauthorization proposal agreed upon by FDA, the Pharmaceutical Research & Manufacturers of America and the Biotechnology Industry Organization, FDA would cut the review time for manufacturing supplements from six to four months.
Advertisement

Related Content

Topical Antimicrobial Proposed Rule Slated For March in “Unified Agenda”
Topical Antimicrobial Proposed Rule Slated For March in “Unified Agenda”
Topical Antimicrobial Proposed Rule Slated For March in “Unified Agenda”
“Complete Response” Reg Proposes Deficiency Letter For Withdrawn NDAs
“Complete Response” Reg Proposes Deficiency Letter For Withdrawn NDAs
“Complete Response” Reg Proposes Deficiency Letter For Withdrawn NDAs

Topics

Advertisement
UsernamePublicRestriction

Register

PS086658

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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