All News

24 SEPTEMBER - Biotechnology Industry Organization (BIO) President Carl B. Feldbaum today issued the following statement regarding White House intentions to nominate Mark B. McClellan, M.D., Ph.D., for commissioner of the Food and Drug Administration, according to newspaper reports:

3 SEPTEMBER - Acambis has completed a Phase 1 trial of it's smallpox vaccine, ACAM1000.

12 AUGUST ? After its fastest review yet for a cancer drug, FDA has approved the colorectal cancer drug Eloxatin (oxaliplatin).

9 JULY - FDA has approved the first device that uses a genetically engineered human protein for use in the lower region of the spine to treat degenerative disc disease, a major cause of back pain for many adults.

8 JULY - FDA will soon publish a Federal Register notice extending the period for public comment on how the agency's regulation of commercial speech can best safeguard public health while complying with First Amendment protections.

1 JULY - NDA Approvals for Calendar Year 2001 http://www.fda.gov/cder/rdmt/ndaaps01cy.htm

28 JUNE - Comprehensive List of Guidance Documents http://www.fda.gov/cder/guidance/guidlist.pdf

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

Blood Products Advisory Committee, Joint Meeting of the Transmissible Spongiform Encephalopathies Advisory Committee and the Blood Products Advisory Committee, and Vaccines and Related Biological Products Advisory Committee

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)

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