- Emergency Preparedness and Response
- Medical Countermeasures Initiative (MCMi)
Guidance for Industry
- Product Development Under the Animal Rule
This guidance provides information and recommendations on drug and biological product development when human efficacy studies are not ethical or feasible.
- M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals and the accompanying Questions and Answers (R2)
The FDA does not have a broad outline or specific list of required studies and/or data needed to review any particular product that is provided to the public since the nonclinical drug development process is product and indication specific. However, the two documents referenced above should be useful starting point towards addressing this topic.
- Formal Meetings Between the FDA and Sponsors or Applicants
- Pre-Investigational New Drug (pre-IND) meetings provide an opportunity to obtain important feedback from FDA on your development program. The process to request these meetings is outlined in the guidance document.
- We recommend that before having an actual pre-IND meeting with the Review Division, a pre-preIND meeting with the Counter-Terrorism and Emergency Coordination Staff (CTECS) be held first. We can help facilitate these pre-preIND meetings between you and the FDA.
- CounterACT grantees should alert and include their program official(s) in meetings with the FDA.
- Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers
Research efforts should always strive to use Animal Doses that are relevant to the Human Equivalent Doses (HED).
- FDA Animal Model Quantification Program within the Drug Development Tools (DDT) Qualification Program