Applications Covered by Section 505(b)(2): Guidance for Industry

U.S. Food and Drug Administration. (1999). Applications Covered by Section 505(b)(2): Guidance for Industry: Guidance for Industry.

Type

Report

Intellectual base

Grey literature

Year

1999

Link

no authoritative link yet

Cited by

1 citation across 1 artifact.

Domain-specific

• Drug Repositioning
  • Regulatory reliance routes such as the U.S. 505(b)(2) pathway still require a complete, legally supportable application and whatever new studies bridge the differences.

Verification

This reference passed the adversarial substantiation pipeline: it was checked to exist and to support the claim it is attached to. See how references were verified.

Registry ID ref:05d208507242 · see in the full table