In Vivo 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


Special Protocol Assessments Get Special Focus In Antibiotic Guidance

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA’s final guidance on use of non-inferiority studies to support antibacterial drug approval is little changed from a 2007 draft version, but it provides further clarity for sponsors operating under a special protocol assessment.

Related Content

FDA Makes It Formal, Rescinds SPA For Amarin’s ANCHOR Study
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
Advisory Committee Splits The Difference On CABP Trials





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