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 Time To Approval, First Action Curves Need To Bend

Executive Summary

FDA generics office says improvement will be noticeable soon, but output can’t dramatically increase overnight.

You may also be interested in...



ANDA Approval Times Get Optimistic Estimate In Budget Request

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

ANDA Approval Times Get Optimistic Estimate In Budget Request

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

FDA Generics Office To Be Managed By Relative Unknown

Director Uhl’s medical leave puts bioequivalence office head John Peters in the limelight.

Topics

UsernamePublicRestriction

Register

PS056844

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