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 Extends Deadline For Continuous Marketing Application Pilot 2 Again

This article was originally published in The Pink Sheet Daily

Executive Summary

The agency is accepting applications for the fast-track IND pilot program until Dec. 31. Applications will only be accepted by those divisions of the drug and biologics centers that have not previously selected a Pilot 2 application.

You may also be interested in...



FDA Cardio-Renal Division Accepts Neurochem’s Fibrillex For Pilot 2 Program

Selection for the continuous marketing application program could expedite review of the amyloidosis treatment, which is targeted for NDA filing in 2005. The pilot 2 program builds upon an earlier collaboration between Neurochem and FDA through which the agency provided funding for a Fibrillex Phase II/III clinical trial.

Pfizer/Eyetech Macugen Filing Complete; NDA Is Part Of FDA’s “Pilot 1”

The wet age-related macular degeneration product will have a mid-December user fee date; an advisory committee is set for August. The NDA was submitted in “reviewable units” under FDA’s pilot program.

Spectrum’s Iso-Vorin Could Clear FDA For Osteosarcoma By First Quarter

The Irvine, Calif., firm also plans sNDAs for a colorectal cancer claim and an oral formulation of the leucovorin relative.

Topics

UsernamePublicRestriction

Register

MT125529

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