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 Can Post On ClinicalTrials.gov, But Unlikely To Use Authority, Agency Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Lack of funding and lack of an enforcement mechanism prevent the agency from taking a more active role in ensuring industry compliance with posting requirements. Sens. Johnson and Dodd appear willing to give FDA more enforcement authority.

You may also be interested in...



ClinicalTrials.gov Compliance Will Improve With Time, PhRMA Suggests

Early stats on industry's posting rate should not be seen as evidence of a "widespread breakdown" in the system, PhRMA declares in a letter to Rep. Waxman. PhRMA believes it can reach full compliance – but suggested it may need several years to do it.

Clinicaltrials.gov: Rep. Waxman Wants PhRMA To Describe Steps To Improve Compliance

Waxman takes issue with PhRMA’s failure to appear at a recent House hearing to discuss FDA’s clinical trial registry. He asks the association to submit documents it has sent to member companies regarding compliance with the submission requirement.

ClinicalTrials.gov Noncompliance By Industry Remains An FDA Concern

Despite “concerted” communications efforts by FDA, only 47% of clinical trials sponsored by industry are listed on registry website. Oncology Division Director Pazdur tells a House hearing that industry reluctance confuses the agency, which acknowledges “limited” enforcement capabilities.

Topics

UsernamePublicRestriction

Register

LL111799

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