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

Postmarketing Study End Of Usefulness Must Be Confirmed By FDA

Executive Summary

Industry must continue to submit status reports on terminated postmarketing drug studies until FDA concurs the studies will provide no more useful information, under a proposed revision to postmarketing study status annual reporting regs.

You may also be interested in...



FDA Phase IV Website Planned For October 2001; Final Tracking Rule Issued

FDA plans to launch a website on the status of pharmaceutical company Phase IV commitments by Oct. 1, 2001.

FDA Phase IV Website Planned For October 2001; Final Tracking Rule Issued

FDA plans to launch a website on the status of pharmaceutical company Phase IV commitments by Oct. 1, 2001.

Sponsors' Failure To Complete Phase IV Studies Should Draw Penalties - HRG

Public Citizen's Health Research Group is calling for FDA to seek authority to levy money penalties in cases where sponsors have failed to complete postmarketing studies requested by the agency.

UsernamePublicRestriction

Register

LL1135495

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