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

Dextroamphetamine Study Should Avoid Prior Stimulant Use, Pediatric Cmte. Says

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA committee accepts recommendation from its Pediatric Ethics Subcommittee to allow a study of dextroamphetamine in healthy children to proceed. Stimulants should not be provided to participants prior to enrollment, committee says.

You may also be interested in...



Attention Deficit Study In Healthy Children Can Proceed Under Certain Conditions, Cmte. Says

NIH proposal to administer dextroamphetamine to healthy children represents only a slightly greater than minimal risk to study participants, FDA's Pediatric Ethics Subcommittee says. The Pediatric Advisory Committee will review the recommendations Sept. 15.

U.S. Patents Could Limit President's AIDS Drug Assistance Plan, GAO Says

The U.S. Global AIDS Coordinator's Office suggests it will use its authority to purchase an FDA-approved generic antiretroviral product for which permission could not be obtained from the patent holder. FDA grants tentative approval to a South African firm for a generic co-packaged version of Combivir and Viramune.

Menactra Pricing Will Be In Line With Wyeth's Prevnar, Sanofi-Aventis Says

Sanofi-Aventis will price its meningococcal conjugate vaccine Menactra in line with Wyeth's pneumococcal vaccine Prevnar

Topics

UsernamePublicRestriction

Register

LL1125120

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