New Approach Methodologies (NAMs) Database of Use Case Examples
Explore practical examples of New Approach Methodologies (NAMs) described in publicly available FDA application review materials. NAMs include a broad range of methods to support the 3Rs (Replacement, Reduction, and Refinement) of testing in animals, such as complex in vitro, 2D in vitro, in chemico and in silico studies. The database is organized around the method, so users can search for a NAM and then examine applications in which it appeared. For additional information about these NAMs, users may also reference the Collection of Alternative Methods for Regulatory Application (CAMERA) database, which describes these and other NAMs in further detail, and the CDER Streamlined Nonclinical Studies and Acceptable NAMs webpage.
Important Information about this Database
This database presents selected examples taken from publicly available FDA review materials for approved drugs to illustrate how NAMs have been included in some specific applications. It is not an exhaustive list, does not constitute FDA guidance or approval of a method for any other use, and should not be interpreted as a recommendation that a particular method will be acceptable in a future submission. The list is provided for illustrative purposes only. Regulatory conclusions are context-specific and may depend on the particular method, endpoint, product, data package, and application. Users should consult applicable FDA regulations and guidance and seek FDA feedback when appropriate. For example, FDA's draft guidance for industry General Considerations for the Use of New Approach Methodologies in Drug Development (March 2026) provides important information for developers seeking to use NAMs in drug development.
NAM Methods and Associated Use Examples
Each row represents a distinct example in the current dataset. Use the search and filter options to narrow the list. Select the link in the Method Name column to open its CAMERA record. To view details about the example, select the link in the Location in FDA Review Document column and navigate to the relevant pages or sections.
| Application Number | Sponsor Name | Drug Name | Method Name | Location in FDA Review Document |
|---|---|---|---|---|
| NDA 210491 | VERTEX PHARMS INC | SYMDEKO (TEZACAFTOR/IVACAFTOR) TABLETS | BCOP | NDA 210491 Review Document pp. 23-26 (BCOP section and Table 11), 41-42 |
| NDA 210491 | VERTEX PHARMS INC | SYMDEKO (COPACKAGED) | EpiSkin SIT | NDA 210491 Review Document pp. 18-20, 41-42 |
| NDA 214787 | GILEAD SCIENCES INC | VEKLURY (REMDESIVIR) | BCOP | NDA 214787 Review Document p. 59 |
| NDA 214787 | GILEAD SCIENCES INC | VEKLURY (REMDESIVIR) | EpiSkin SIT | NDA 214787 Review Document p. 59 |
| NDA 214902 | MAYNE PHARMA | TWYNEO (BENZOYL PEROXIDE; TRETINOIN) | BCOP | NDA 214902 Review Document p. 45 |
| NDA 215064 | CHIESI (AMRYT PHARMACEUTICALS) | FILSUVEZ (BIRCH TRITERPENES) | BCOP | NDA 215064 Review Document pp. 38, 49 |
| NDA 215974 | GILEAD SCIENCES INC | SUNLENCA (LENACAPAVIR SODIUM) | h-CLAT | NDA 215974 Review Document p. 164 |
| NDA 215974 | GILEAD SCIENCES INC | SUNLENCA (LENACAPAVIR SODIUM) | DPRA | NDA 215974 Review Document p. 164 |
| NDA 216158 | BRISTOL-MYERS | COBENFY (TROSPIUM CHLORIDE; XANOMELINE TARTRATE) | KeratinoSens | NDA 216158 Review Document p. 177 (Table 116) |
| NDA 216158 | BRISTOL-MYERS | COBENFY (TROSPIUM CHLORIDE; XANOMELINE TARTRATE) | h-CLAT | NDA 216158 Review Document p. 177 (Table 116) |
| NDA 216158 | BRISTOL-MYERS | COBENFY (TROSPIUM CHLORIDE; XANOMELINE TARTRATE) | DPRA | NDA 216158 Review Document p. 177 (Table 116) |
| NDA 216873 | GLAXOSMITHKLINE | OJJAARA (MOMELOTINIB DIHYDROCHLORIDE) | Corrositex | NDA 216873 Review Document p. 216 (Table 129) |
| NDA 216873 | GLAXOSMITHKLINE | OJJAARA (MOMELOTINIB DIHYDROCHLORIDE) | BCOP | NDA 216873 Review Document p. 216 (Table 129) |
| NDA 217242 | ARCUTIS | ZORYVE (OFLUMILAST) | BCOP | NDA 217242 Review Document pp. 27, 34 |
| NDA 217347 | BOTANIX SB | SOFDRA (SOFPIRONIUM BROMIDE) | BCOP | NDA 217347 Review Document pp. 30, 59 |
| NDA 217424 | LNHC | ZELSUVMI | BCOP | NDA 217424 Review Document p. 58 (Section 5.5.5.2) |
| NDA 218276 | NOVARTIS | FABHALTA (IPTACOPAN HYDROCHLORIDE) | EpiSkin SIT | NDA 218276 Review Document p. 184 (Table 115) |
| NDA 218881 | ELI LILLY AND CO | INLURIYO | BCOP | NDA 218881 Review Document p. 80 |
| NDA 219083 | CYTOKINETICS | MYQORZO (AFICAMTEN) | KeratinoSens | NDA 219083 Review Document p. 114 (Section 13.1.5.2) |
| NDA 219083 | CYTOKINETICS | MYQORZO (AFICAMTEN) | DPRA | NDA 219083 Review Document p. 114 (Section 13.1.5.2) |
| NDA 219083 | CYTOKINETICS | MYQORZO (AFICAMTEN) | U-SENS | NDA 219083 Review Document p. 114 (Section 13.1.5.2) |
| NDA 219083 | CYTOKINETICS | MYQORZO (AFICAMTEN) | EpiDerm SIT | NDA 219083 Review Document p. 114 (Section 13.1.5.2) |
| NDA 219083 | CYTOKINETICS | MYQORZO (AFICAMTEN) | Corrositex | NDA 219083 Review Document p. 114 (Section 13.1.5.2) |
| NDA 219083 | CYTOKINETICS | MYQORZO (AFICAMTEN) | BCOP | NDA 219083 Review Document p. 114 (Section 13.1.5.2) |
| NDA 219209 | VERTEX PHARMS INC | JOURNAVX | EpiSkin SIT | NDA 219209 Review Document p. 127 (Tables 103-104) |