New Drug and Biologics Development and FDA Approval: Overview | Practical Law

New Drug and Biologics Development and FDA Approval: Overview | Practical Law

A Practice Note describing the US drug and biologics development and FDA approval processes. This Note discusses preclinical and clinical testing, investigational new drug applications (INDs), FDA review of marketing applications, including 505(b)(1) and 505(b)(2) new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) for generic drug products.

New Drug and Biologics Development and FDA Approval: Overview

Practical Law Practice Note Overview w-002-9740 (Approx. 29 pages)

New Drug and Biologics Development and FDA Approval: Overview

by Practical Law Commercial Transactions
Maintained • USA (National/Federal)
A Practice Note describing the US drug and biologics development and FDA approval processes. This Note discusses preclinical and clinical testing, investigational new drug applications (INDs), FDA review of marketing applications, including 505(b)(1) and 505(b)(2) new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) for generic drug products.