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

Financial Disclosure Reports May Be Required For Pharmacodynamic Studies

Executive Summary

Pharmacodynamic studies may be included in "covered" studies for the purposes of FDA's financial disclosure guidance if the study is critical to an application filing.

You may also be interested in...



Financial Disclosure Applies To Firms Providing Drugs For Public Studies

Pharmaceutical companies that contribute drugs to publicly funded studies used to support marketing applications will be responsible for collecting investigator financial interest information, an updated financial disclosure guidance notes.

Clinical Investigator Financial Interest Inquiries May Be Costly For Industry

Clinical trial sponsors face "prohibitive" costs in developing internal mechanisms to verify clinical investigators' financial interests in the sponsor company, R.W. Johnson's Janice Little said at the Drug Information Association's annual meeting in Baltimore June 29.

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

UsernamePublicRestriction

Register

LL1132098

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