FDA Approval Process for Biologics

I need to know about the Food and Drug Administration Approval Process for Biologics so please can you give me the FDA Approval Process for Biologics?

[Arvind Kumar]

You need to know about the Food and Drug Administration Approval Process for Biologics.
So here I am uploading PDF file of complete information and knowledge for the particular topic.

PDF file has following type of information.

I. Biologics
II. Current Regulatory Framework
A. Public Health Service Act vs. Food, Drug,
and Cosmetic Act
B. Hatch-Waxman 505(j)
C. Hatch-Waxman 505(b)(2)
III. Legislation
A. Need for New Legislation
B. Economic Concerns.
C. Health and Safety Concerns
D. Hatch-Waxman Lessons
1. New Chemical Entity Exclusivity