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

Clinical Study Disclosures Will Make Drug Reviews More Efficient – Gottlieb

Executive Summary

US FDA pilot program linking drug approval documents to sponsors' clinical study reports will improve review efficiency and access to information by medical researchers and drug developers, commissioner says; move also could aid sponsors when it comes to reimbursement decision-making, Foley and Lardner's Rosen predicts.

You may also be interested in...



Clinical Study Report Release Could Compromise Patient Privacy, Groups Say

US FDA's plan to post CSRs may also inadvertently release confidential commercial information, agency is warned by industry groups.

US FDA May Scrap Clinical Study Report Disclosure For New Drug Approvals

The pilot project former Commissioner Gottlieb championed found only one sponsor interested in participating.

Postmarketing Commitments: Sponsors Often Do Not Publish Results Of New Clinical Trials

Only 15% of postmarketing commitments for drugs approved in 2009-2012 were for clinical trials and only half of these were published, study finds; authors call for US FDA to provide more trial information.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS122329

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