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

GSK Avandamet Cost-Effectiveness For Pediatric Use Will Be Studied By NIH

This article was originally published in The Pink Sheet Daily

Executive Summary

The study will randomize 750 children aged 10-17 to a regimen of Avandamet, metformin or metformin plus lifestyle change.

You may also be interested in...



Lupus Guidance Suggests Broad Use Of Health-Related Quality Of Life Endpoint

FDA’s draft guidance on systemic lupus erythematosus drug development lists four possible claims that the agency “may be willing to approve”: reduction in disease activity; organ-specific lupus treatment; complete clinical response/remission; and reduction in flares.

Risk Management Guidance Suggests Using Claims Data To Evaluate Safety Signals

Three FDA risk management final guidances recommend that sponsors collect a wide range of safety data during both the clinical trial and postmarketing periods of drug development. The agency suggests that sponsors hold discussions with FDA before settling on drug study designs or postmarketing activities.

RiskMAP Guidance Includes Plans For A Website

FDA is planning to develop a Risk Minimization Action Plan website, an agency risk management guidance states

Topics

UsernamePublicRestriction

Register

MT101489

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