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Novel Alternative Methods (NAMs) Validation and Qualification...
advance research that will lead to new therapies, diagnostics, and potential cures ... We accelerate prevention, new therapies, diagnostics & potential cures We advance global ...
Size: 3.7MB https://ntp.niehs.nih.gov/sites/default/files/2024-10/2-6_Adam_SACATM2024_508.pdf -
ICCVAM Public Forum: May 2023
Measurement Science in ICCVAM: Elijah Petersen, NIST In Vitro Co-Culture Assays to Assess Safety of CAR-T Cell Therapies: Shari Price, Leidos Biomedical Research (contractor ...
https://ntp.niehs.nih.gov/whatwestudy/niceatm/3rs-meetings/past-meetings/pubforum-2023/iccvamforum-2023 -
FDA Guidance: Instructions and Template for Chemistry, Manufacturing...
Office of Cellular, Tissue, and Gene Therapies at 301-827-5102. U.S. Department of ... In order to deliver a safe and effective product, human somatic cell therapies present ...
Size: 338KB https://ntp.niehs.nih.gov/iccvam/suppdocs/feddocs/fda/fda_cmcsomcell.pdf -
FDA Guidance: Content and Review of Chemistry, Manufacturing...
Office of Cellular, Tissue, and Gene Therapies at 301-827-5102. U.S. Department of ... In order to deliver a safe and effective product, human gene therapies present many ...
Size: 400KB https://ntp.niehs.nih.gov/iccvam/suppdocs/feddocs/fda/fda_gtindcmc.pdf -
FNIH Overview for ICCVAM (ICCVAM 2024 Public Forum)
advance research that will lead to new therapies, diagnostics, and potential cures. 4 ... We advance global health & seek equity in care We accelerate prevention, new therapies, ...
Size: 4.8MB https://ntp.niehs.nih.gov/sites/default/files/2024-06/14_Conners_ICCVAMPublicForum2024_508.pdf -
Regulatory Applications of 3Rs
The U.S. Food and Drug Administration (FDA) has announced a plan to replace animal testing in the development of monoclonal antibody therapies and other drugs with more effective, ...
https://ntp.niehs.nih.gov/whatwestudy/niceatm/accept-methods/apps -
Notices
... (both autologous and allogeneic cell therapies). (3) viral-based nucleic acid systems ... For many autoimmune diseases there are no FDA- approved therapies, underscoring that there ...
Size: 208KB https://ntp.niehs.nih.gov/sites/default/files/2025-07/FR-2025-12480.pdf -
RoC Profile: Nitrosourea Chemotherapeutic Agents; 15th RoC 2021
... use with other anti- cancer therapies in the treatment of preexisting cancer (IARC 1987). ... nonlymphocytic leukemia among 1,566 patients given other therapies (Boice et al. 1983). ...
Size: 215KB https://ntp.niehs.nih.gov/sites/default/files/ntp/roc/content/profiles/nitrosoureachemotherapeuticagents.pdf -
RoC Profile: Norethisterone; 15th RoC 2021
... and dysmenorrhea, and in hormone replace- ment therapies (IARC 1979, MedlinePlus 2009b). ... Norethisterone acetate is also administered in several hormone replacement therapies ...
Size: 123KB https://ntp.niehs.nih.gov/sites/default/files/ntp/roc/content/profiles/norethisterone.pdf -
RoC Profile: Progesterone; 15th RoC 2021
... or estrogen-progesterone combinations used as oral contraceptives or menopausal therapies. ... uterine bleeding and in combination hormone-replacement therapies (MedlinePlus 2009). ...
Size: 138KB https://ntp.niehs.nih.gov/sites/default/files/ntp/roc/content/profiles/progesterone.pdf
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