FDA
News Digest
November 22, 2004
___________________________________________________________
IN
THIS WEEK'S ISSUE
-- FDA Responds to Allegations About
Vioxx, Drug Safety
-- Rules Finalized to Improve
Safety of Human Donor Cells, Tissue
-- 'Smart' Tags to Help
Avoid Surgical Errors, Identify Rx Drugs
-- FDA Proposes Guidance for
Evaluating New Proteins in Plants
-- Lung Cancer Drug Tarceva
Approved; Shows Improved Survival
-- Labeling Changes Announced for
Mifepristone, Depo-Provera
-- Recalls/Market
Withdrawals
-- Congressional
Testimony
-- Public
Meetings
___________________________________________________________
FDA Responds to Allegations About
Vioxx, Drug Safety
Three FDA officials have responded
to allegations related to the approval and postmarket review of the arthritis
drug Vioxx, and about the agency's
drug safety activities in general. Included is a statement by Steven Galson,
M.D., acting director of the FDA Center for Drug Evaluation and Research, that
recent congressional testimony by David Graham, M.D., associate director of the
FDA Office of Drug Safety, does not reflect the agency's
views.
-- Statement by FDA Acting Commissioner Lester M. Crawford, D.V.M.: http://www.fda.gov/bbs/topics/news/2004/NEW01136.html
-- Statement by Acting Director of the FDA Center for Drug Evaluation and Research Steven Galson, M.D.: http://www.fda.gov/bbs/topics/news/2004/NEW01138.html
-- Testimony by Deputy Director of the FDA Office of New Drugs Sandra Kweder, M.D.: http://www.fda.gov/ola/2004/vioxx1118.html
Rules Finalized to Improve
Safety of Human Donor Cells, Tissue
FDA has finalized the last of three
rules in its plan to improve the safety of a broad range of human donor cell and
tissue products. These products include musculoskeletal tissue, corneas,
human heart valves, dura mater (brain lining), and cellular therapies.
-- Press release: http://www.fda.gov/bbs/topics/news/2004/NEW01137.html
-- Questions and answers: http://www.fda.gov/cber/rules/gtpq&a.htm
'Smart' Tags to Help Avoid
Surgical Errors, Identify Rx Drugs
FDA has cleared for marketing a tag
that uses "smart" technology to mark an anatomical site for surgery. Called the
SurgiChip Tag Surgical Marker system, the device is intended to minimize the
chance of wrong-site, wrong-procedure, or wrong-patient surgeries. It is the
first such marker to use radio frequency identification (RFID), a burgeoning
technology with many future applications, including tags for prescription drugs
to help thwart counterfeiters.
-- Surgical tag: http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01326.html
-- Prescription drugs tag: http://www.fda.gov/bbs/topics/news/2004/NEW01133.html
FDA Proposes Guidance for Evaluating
New Proteins in Plants
To help ensure that material from
new plant varieties intended for food use doesn't accidentally enter the food
supply before FDA has evaluated its safety, the agency has proposed an industry
guidance that describes how companies should consult with FDA early in product
development.
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01327.html
Lung Cancer Drug Tarceva Approved;
Shows Improved Survival
FDA has approved Tarceva tablets to
treat non small-cell lung cancer, the most common form of lung cancer in the
United States. The drug is intended for patients whose cancer has progressed
despite other treatments, including at least one chemotherapy regimen. In
clinical trials, the drug was shown to improve survival time.
http://www.fda.gov/bbs/topics/news/2004/NEW01139.html
Labeling Changes Announced for
Mifepristone, Depo-Provera
FDA has announced that the labeling
for Mifepristone, approved for termination of early pregnancy, will include new
information on possible adverse effects, including the risk of serious
bacterial infections, sepsis, bleeding, and death. Also announced was new "black
box" labeling for the contraceptive Depo-Provera, warning that prolonged use may
result in loss of bone density.
-- Mifepristone: http://www.fda.gov/bbs/topics/news/2004/NEW01134.html
-- Depo-Provera: http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01325.html
___________________________________________________________
RECALLS/MARKET
WITHDRAWALS
No recall press releases were issued
in the past week.
For a list of recalls, market
withdrawals, and safety alerts involving FDA-regulated products from the last 60
days, go to
http://www.fda.gov/opacom/7alerts.html
To access the RSS feed of FDA
recalls information, go to
http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml
__________________________________________________________
CONGRESSIONAL
TESTIMONY
FDA Acting Commissioner Lester M.
Crawford, D.V.M., before the Senate Special Committee on Aging; subject: FDA's
ongoing efforts to ensure the safety, effectiveness, and availability of
influenza and other vaccines (Nov. 16)
http://www.fda.gov/ola/2004/vaccines1116.html
To view an archive of FDA congressional testimony, go to http://www.fda.gov/ola/listing.html
__________________________________________________________
PUBLIC MEETINGS
Dec. 2 -- Advisory Committee for Reproductive
Health Drugs; under discussion: pending application for a testosterone
patch for surgically menopausal women (Gaithersburg,
Md.)
http://www.fda.gov/oc/advisory/accalendar/2004/cder12537d120204.html
For a list of FDA meetings,
seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html
__________________________________________________________
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