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


FDA Has “Issues” With NDAs; Half Of 74-Day Letters Note Application Flaws

This article was originally published in The Tan Sheet

Executive Summary

Roughly half of the 74-day "issue" letters sent by FDA to NDA applicants in the first six months of the agency's 2003 fiscal year have noted application flaws, Office of New Drugs Director John Jenkins, MD, said at Temple University's annual industry/FDA conference in Philadelphia April 15

You may also be interested in...

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

NDA Reviews To Be Studied Prospectively To Identify Best First-Cycle Practices

FDA is planning a prospective study on the root causes of multiple-cycle drug and biologic reviews as part of an effort to improve the review process, Commissioner Mark McClellan, MD/PhD, announced Jan. 31

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC





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