FDA [to 31 October2015]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm

.
:: Influenza Virus Vaccine for the 2015-2016 Season
Posted: 10/28/2015

.
:: Product Development Under the Animal Rule; Guidance for Industry (PDF – 563KB)
Posted: 10/27/2015
INTRODUCTION
This guidance provides information and recommendations on drug and biological product3 development when human efficacy studies are not ethical or feasible. The regulations that set forth the pathway for approval4 of these products under 21 CFR 314.600 through 314.650 (drugs) or 21 CFR 601.90 through 601.95 (biological products) are commonly referred to as the Animal Rule…