Comment from Anonymous
AnonymousSupportIndividual
Summary: The commenter asks why the specific procedures for meetings regarding animal model development for countermeasures (mandated by PAHPRA 2013) are not included in the draft guidance, suggesting they should be incorporated.
PAHPRA 2013 resulted in the inclusion of the following in 565(d): To facilitate the timely development of animal models and support the development, stockpiling, licensure, approval, and clearance of countermeasures, the Secretary shall, not later than 180 days after March 13, 2013, establish a procedure by which a sponsor or applicant that is developing a countermeasure for which human efficacy studies are not ethical or practicable, and that has an approved investigational new drug application or investigational device exemption, may request and receive-
(A) a meeting to discuss proposed animal model development activities; and
(B) a meeting prior to initiating pivotal animal studies.
My understading is that this has been incorporated into a the PDUFA meeting schedule. Is there a reason to not include it in this guidance?