Emergency Preparedness and Response

Animal Rule Information

Overview | For product sponsors | New! Electronic data standards | Animal Rule links and product approvals


Gloved hand working with lab equipment at FDA headquarters at White Oak, MDBefore a medical product can be approved by FDA, the sponsor must prove efficacy—that the product works. In some cases, such as developing medical countermeasures (MCMs) for potential bioterror threats, human challenge studies (exposing people to the threat agent) would not be ethical or feasible.

In these cases, FDA may grant approval based on well-controlled animal studies, when the results of those studies establish that the drug or biologic product is reasonably likely to produce clinical benefit in humans. The product sponsor must still demonstrate the product’s safety in humans.

For product sponsors

FDA strongly encourages MCM sponsors to establish early and ongoing communications with FDA. 

The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (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” (IND and IDE, respectively) 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. More MCM-related counterterrorism legislation

Drug Products and Biologics
Guidance for Industry: Product Development Under the Animal Rule (PDF, 574 KB)

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, in addition to the guidance linked above:

  1. Draft Guidance for Industry - Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (December 2017) (PDF, 156 KB)
  2. FDA’s Drug Development Tools Qualification Programs
Medical Devices

Sponsors or applicants developing a medical device should first consult Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff (September 2017) (PDF, 297 KB).

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  

New! Electronic data standards for Animal Rule studies

FDA has been working with the Critical Path Institute disclaimer icon and the Clinical Data Interchange Standards Consortium (CDISC disclaimer icon) to develop electronic data standards for the natural history and efficacy studies conducted in animals that support Animal Rule applications.

Notice of upcoming comment periods and webinar

CDISC SENDIG-AR comment period
The draft Standard for Exchange Nonclinical Data (SEND) Implementation Guide for Animal Rule studies (SENDIG-AR) will be available for public review and comment on the CDISC website disclaimer icon by February 25, 2019, with the comment period closing on April 12, 2019.  

CDISC SENDIG-AR public webinar
A free webinar providing an overview of the SENDIG-AR is scheduled for March 5, 2019, 11:00 a.m. – 12:30 p.m. ETRegister disclaimer icon by March 5, 2019.
Controlled terminology comment period
Critical to the development of data standards is the development of appropriate controlled terminology.  A major portion of the controlled terminology associated with the new SENDIG-AR has already completed its public comment period. It is anticipated that the remaining portion of the controlled terminology will be posted for public review and comment from March 22 – April 19, 2019, at CT-P38-Link. disclaimer icon  (The preceding link will be activated on March 22, 2019, and will not work until that date.)

Product Approval Information

FDA news announcements for products approved under the Animal Rule. For more information about Animal Rule approvals of CDER-regulated products, click the button at the bottom of this list.

Page Last Updated: 02/12/2019
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