News

FDA and AstraZeneca have added a boxed warning and strengthened the Warnings section of the Nolvadex (tamoxifen citrate) tablets label to inform healthcare professionals about new risk information. MedWatch Safety Information http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#nolvad

Industry news on investors, software validation guidance, mergers and aquisitions, new drugs on the market, a Science Advisory Board that helps vendors understand life-science needs, a new FDA inspection paradigm, and licensing priorities.

FDA Science Forum, info on contact lenses, FDA regional director becomes Rear Admiral

Flu vaccine, biologic product approvals, foreign establishment registration, and vacancy announcement

Original manufacturing supplements, original efficacy supplements, original and resubmitted NDAs, and new and generic drug approvals.

New guidances, meetings, and 2001 biologics product approval

Industry Business News: FOI Services, Inc. has provided access to Freedom of Information Act files covering virtually every aspect of the U.S. approval and regulation of pharmaceuticals, medical devices, biologics, and diagnostics.

USP's official standards publication, USP 25-NF 20, became official on 1 January 2002. It will now be followed by two Supplements -- one in February and one in June -- becoming official in April and August 2002.

Recall of reagent red blood cells (two notices) and advisory committee meetings

New and Generic Drug Approvals [Includes Drug Label and Approval Letter] (Updated 12/27/2001)

Potency testing following nine weeks storage at room temperature found that the lots fell below the minimum potency specification.

Guidance for Industry: General Principles of Software Validation; Final Guidance for Industry and FDA Staff

Preapproval inspection of anthrax facility, new defribilator, new FDA group on safety and risk, and noodle recall.

Drug approvals for 2001 and new approvals

Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products

Drug approvals

CDER News 12/10-12/11

What's New on the CBER Web Site 12/3/2001 through 12/7/2001

CBER Recall of Hepatitis A Vaccine, Inactivated (VAQTA) Packaged in single-dose prefilled syringes, posted 10 December 2001

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/