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

Generic Priority Review Expanded In Senate User Fee Bill

Executive Summary

Amendment added during markup would require eight-month review of ANDAs for shortage drugs and those with limited competition, as well as pre-submission meetings.

You may also be interested in...



New ANDA Review Pathways: Should You Be A Priority Or Expedited?

Amid confusion about multiple priority and expedited pathways for US generic drug applications, industry asks which are a true advantage.

New ANDA Review Pathways: Should You Be A Priority Or Expedited?

Amid confusion about multiple priority and expedited pathways for US generic drug applications, industry asks which are a true advantage.

ANDA Sponsors Get Wide-Open Facility Deadline For Priority Review

User fee legislation says facility information to qualify for priority review must arrive two months in advance of ANDA, conflicting with narrow 'window' in FDA's draft guidance.

Related Content

Topics

UsernamePublicRestriction

Register

GB150366

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