Ropes & Gray: Congress Authorizes Abbreviated Regulatory Pathway for FDA Approval of Biological Products | Practical Law

Ropes & Gray: Congress Authorizes Abbreviated Regulatory Pathway for FDA Approval of Biological Products | Practical Law

This Ropes & Gray LLP memorandum discusses the authorization under Congressional health care reform of the Food and Drug Administration (FDA) to approve biological products through an abbreviated regulatory pathway that does not require these products to undergo full clinical testing.

Ropes & Gray: Congress Authorizes Abbreviated Regulatory Pathway for FDA Approval of Biological Products

by Ropes & Gray LLP
Published on 30 Mar 2010 • USA (National/Federal)
This Ropes & Gray LLP memorandum discusses the authorization under Congressional health care reform of the Food and Drug Administration (FDA) to approve biological products through an abbreviated regulatory pathway that does not require these products to undergo full clinical testing.