Statements (28)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
FDA regulatory pathway
|
| gptkbp:allows |
reliance on data not developed by applicant
|
| gptkbp:applicantMayReference |
published literature
FDA's previous findings of safety and effectiveness |
| gptkbp:appliesTo |
drugs with changes from approved products
|
| gptkbp:compatibleWith |
generic drugs identical to reference listed drug
|
| gptkbp:contrastsWith |
505(b)(1) application
505(j) ANDA |
| gptkbp:definedIn |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:enables |
cost savings for applicants
faster drug development |
| https://www.w3.org/2000/01/rdf-schema#label |
505(b)(2) application
|
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:requires |
bioequivalence studies
bridging studies clinical data if necessary submission of NDA to FDA |
| gptkbp:section |
Section 505(b)(2) of the FD&C Act
|
| gptkbp:subject |
exclusivity provisions
patent certification requirements |
| gptkbp:usedFor |
combination products
approval of new drug applications modifications of approved drugs new dosage forms new routes of administration new strengths |
| gptkbp:bfsParent |
gptkb:21_U.S.C._§_355
|
| gptkbp:bfsLayer |
8
|