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

ANDA Review: Moving From Tentative To Final Approval Could Require 10 Months Or More

Executive Summary

US FDA draft guidance says substantive changes to reference product may require major ANDA amendment and 10-month review goal for the generic.

You may also be interested in...



FDA's Post-Shutdown ANDA Bolus Could Be Massive

More than 300 generic drug applications might be officially filed when the shutdown ends, substantially increasing stress on assessors and other Office of Generic Drugs staff.

US Federal Courts Can Operate Until Jan. 25; Patent Office Faces Eminent Closure Under Shutdown

Federal courts and USPTO will soon run out of funds that have allowed them to continue normal operations; pending ANDAs to get same filing date, which could lead to FDA legal challenges.

Shutdown Week Four: FDA Maintains Pre-Shutdown Output Pace In Some Cases

ANDA and NDA/BLA supplement approvals continue thanks to carryover user fee funds, but US FDA hasn't made any NDA and BLA approvals during shutdown as as anxiety over effect of "lapse period" on agency increases.

Related Content

Topics

UsernamePublicRestriction

Register

PS124682

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