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

MEDICAL PRIVACY LAWS SHOULD NOT REQUIRE PATIENT CONSENT FOR POST-MARKETING REGISTRIES -- PhRMA; LIMITS ON RIGHTS TO RECORDS IN CLINICALS SUGGESTED

Executive Summary

Medical privacy legislation should not require sponsors to obtain patient consent for post-marketing registries when subjects are not identifiable, Glaxo Wellcome VP-Worldwide Clinical Research Richard Kent maintained at a Feb. 4 HHS hearing on medical privacy. Kent cited as an example Glaxo Wellcome's registry for the anti-convulsant Lamictal, which was established to determine whether the drug is teratogenic in humans.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS029695

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