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

Pediatric Studies for PPIs: Are Placebo-Controlled Trials In Infants Unethical?

Executive Summary

FDA is asking its pediatric advisory subcommittee to consider whether the agency's requirements for pediatric studies of proton pump inhibitors in infants under one year of age raise ethical concerns

You may also be interested in...



FDA Pediatric Therapeutics Office To Consider Ethics, Postmarket Safety

FDA is in the process of hiring an epidemiologist to coordinate epidemiology and safety reviews of approved pediatric products within the newly created Office of Pediatric Therapeutics

Abbott Will Outlicense Ketolide Antibiotic, Focus On Quinolone And D2E7

Abbott is seeking to outlicense its ketolide antibiotic ABT-773 in lieu of expanding Phase III development to address class issues

Abbott Will Outlicense Ketolide Antibiotic, Focus On Quinolone And D2E7

Abbott is seeking to outlicense its ketolide antibiotic ABT-773 in lieu of expanding Phase III development to address class issues
UsernamePublicRestriction

Register

PS039984

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