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PDP for a Generic Prophylactic Vaccine for Infectious Diseases

https://www.niaid.nih.gov/sites/default/files/pdp-generic-vaccine-2023.pdf
PDF Document | 1.23 MB
Product Development Plan (PDP) for a Generic Prophylactic Vaccine for Infectious Diseases

Last Reviewed: September 30, 2023

PDP for Small Molecule Anti-infectives

https://www.niaid.nih.gov/sites/default/files/small-molecule-pdp-revised.pdf
PDF Document | 2.44 MB

Last Reviewed: March 31, 2025

PDP for Human Monoclonal Antibodies

https://www.niaid.nih.gov/sites/default/files/mab-pdp-508-compressed.pdf
PDF Document | 902.63 KB
Generic Preclinical Development Plan for Human Monoclonal Antibodies

Last Reviewed: August 1, 2024

Product Development Plans, Checklists, and Target Product Profiles

The generic product development plans (PDPs) and target product profiles (TPPs) below provide guidance to support product development activities through Phase 1 clinical development: PDP for Human Monoclonal Antibodies PDP for Small Molecule Anti-infectives PDP for a Generic Prophylactic Vaccine for Infectious Diseases TPPs for Antivirals

Last Reviewed: April 17, 2025