News

FDA NEWS DIGEST -- December 17, 2001

Drug Approvals [Includes Drug Label and Approval Letter] (Updated 12/18/2001)

USP invites you to take a tour of its new E-newsroom

FDA final rule requiring foreign drug and biologics manufacturers to register their operations and products. Takes effect 11 Feb 2002

New and generic drug approvals

Approvals, warnings, hazards, and sentencing

The purpose of this guidance document is to inform all establishments engaged in the manufacture of Source Plasma that FDA, has approved nucleic acid tests (NAT) to identify human immundeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) in Source Plasma donations; 2) that it believes that a licensed nucleic acid test to identify HIV and HCV in Source Plasma donations, when available, should be used to adequately and appropriately reduce the risk of transmission of these communicable diseases; and 3) that it expects that a licensed nucleic acid test to identify HIV-1 and HCV in Source Plasma donations will be available after establishments submit biological license application (BLA) supplements providing for the use of an approved nucleic acid test, and after we have approved such supplements.

As of 12/04/2001CDER, Warning and Untitled Letters for 2001, new and generic drug approvals, drug approval packages, and labeling updates.

CDER News 12/03/

FDA's news digest for events and activities at FDA during the week of 3 December 2001.

FDA's news digest for events and activities at FDA during the week of 19 November 2001