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PDP for Small Molecule Anti-infectives
https://www.niaid.nih.gov/sites/default/files/small-molecule-pdp-revised.pdf
Last Reviewed: March 31, 2025
PDP for Human Monoclonal Antibodies
https://www.niaid.nih.gov/sites/default/files/mab-pdp-508-compressed.pdf
Last Reviewed: August 1, 2024
PDP for a Generic Prophylactic Vaccine for Infectious Diseases
https://www.niaid.nih.gov/sites/default/files/pdp-generic-vaccine-2023.pdf
Last Reviewed: September 30, 2023
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
Information about the NIAID Office of Clinical Research Policy and Regulatory Operations (OCRPRO) mission and contacts.
Last Reviewed: December 13, 2021
NIAID supports a number of diagnostics to combat antibiotic resistance, including multiplex platforms such as the FilmArray Blood Culture Identification Panel by BioFire Diagnostics LLC, an affiliate of Biomérieux.
Last Reviewed: November 18, 2024
Regional Group D West - map
https://www.niaid.nih.gov/sites/default/files/gmp-map-d.pdf
Last Reviewed: October 19, 2023
NIAID maintains contracts to support the development of emerging HIV therapeutics, vaccines, and non-vaccine biomedical prevention (nBP) candidates. As promising adult and pediatric formulations emerge for the treatment and prevention of HIV and co-infections, there is a critical need to move these candidates rapidly and efficiently into clinical testing. The services under these contracts are
Last Reviewed: August 11, 2023