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

FDA Standard Drug Review Goals Could be Lengthened By 1-2 Months, IG Says

This article was originally published in The Tan Sheet

Executive Summary

FDA should consider extending by one or two months its 10-month goal for standard drug reviews, the HHS Inspector General said in a 1report released March 25

You may also be interested in...



John Taylor Temporarily Replaces Sharfstein As FDA's Second-In-Command

John Taylor, counselor to FDA Commissioner Margaret Hamburg, will serve temporarily as second-in-command while Hamburg considers how to reorganize the agency's leadership following Principal Deputy Commissioner Josh Sharfstein's departure.

FDA “Refuse-To-File” Decisions Encouraged For Incomplete, Poor NDAs – IG

FDA should consider issuing "refuse-to-file" decisions more often for incomplete or inadequate NDAs, the HHS Inspector General recommended in a report released March 25

FDA “Refuse-To-File” Decisions Encouraged For Incomplete, Poor NDAs – IG

FDA should consider issuing "refuse-to-file" decisions more often for incomplete or inadequate NDAs, the HHS Inspector General recommended in a report released March 25

Topics

UsernamePublicRestriction

Register

LL029263

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