Pink Sheet is part of the Business Intelligence Division 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

Anti-Infective Drugs Committee

Executive Summary

FDA Anti-Infective Drugs Division's draft "points to consider" document will be discussed by the panel Oct. 27. The committee will discuss "the need for 'two adequate and well controlled studies'" in antimicrobial drug clinical development. When the document, which outlines anti-infective drug policy, was discussed by the advisory committee last year, some companies found its requirement of 10 evaluable patients per arm in a two-arm study problematic ("The Pink Sheet" Nov. 18, 1991, T&G-2).
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS021506

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