Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
The new law also recognizes the key role FDA plays in emergency preparedness and response. Its provisions further FDA’s mission of fostering the development and availability of drugs, vaccines, and devices (medical countermeasures), for use in these emergencies. PAHPRA also builds on FDA’s ongoing efforts to enhance review processes and advance regulatory science for MCM development.
Together, these new authorities for FDA will not only support and facilitate government partners’ pre-event planning efforts and pre-positioning of MCMs, but will also help to facilitate MCM development and the efficient and rapid deployment of these medical products in the event of a CBRN emergency or emerging disease health threat. FDA looks forward to implementing the new provisions in PAHPRA to support our Nation’s preparedness and response capabilities, and continuing to provide the highest quality and most timely guidance possible to all stakeholders engaged in MCM product development.
PAHPRA Legislative Information and Text
PAHPRA Developments and Updates
• Development and Animal Modeling Procedures under Section 304 of PAHPRA
FDA strongly encourages sponsors of medical countermeasures to establish early and ongoing communications with FDA. PAHPRA added a new section 565(d) of the FD&C Act to require that FDA establish a procedure for a sponsor or applicant 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” (IDE) to request and receive two meetings with FDA – one meeting to discuss “proposed animal model development activities” and a second meeting prior to initiating pivotal animal studies.
FDA intends to rely on its existing procedures for arranging formal meetings with sponsors and applicants to enable them to request and receive the meetings provided in section 565(d). Thus, sponsors or applicants developing drug products should consult the following resources for detailed information about the process and expectations for meetings about product development under the Animal Rule, including those requested pursuant to section 565(d): (1) Guidance for Industry - Formal Meetings Between the FDA and Sponsors or Applicants (May 2009)
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; and (2) FDA’s Drug Development Tools website
Sponsors or applicants developing a medical device should first consult Draft Guidance for Industry and FDA Staff: The Pre-Submission Program and Meetings with FDA Staff (July 2012)
. The process and expectations for meetings outlined in this guidance are relevant for any meeting prior to a medical device pre-market submission (including an IDE, pre-market application (PMA) or 510(k)). Once a premarket medical device submission has been submitted, meetings, including a second meeting “prior to initiating animal studies,” will be conducted pursuant to the applicable pre-market submission (e.g., PMA, 510(k)) review process. Additional information regarding the regulatory process for medical device pre-market submissions can be found by clicking here