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

ANDA Approval Times Get Optimistic Estimate In Budget Request

Executive Summary

US FDA has historically overestimated generic review performance in budget requests, but recently underestimated the number of ANDAs it expects to approve.

You may also be interested in...



ANDA Median Approval Times Still Rising, But What Does It Mean?

First quarterly report of median US generic drug times shows longer time to approval than previous estimates, but that may not tell stakeholders much.

ANDA Median Approval Times Still Rising, But What Does It Mean?

First quarterly report of median US generic drug times shows longer time to approval than previous estimates, but that may not tell stakeholders much.

US FDA Wants To Predict ANDA Complete Response Responses

Generic industry, FDA discuss potential ways to increase transparency so agency can better estimate when – and even whether – an ANDA receiving a complete response will be returned.

Related Content

Topics

UsernamePublicRestriction

Register

LL111109

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