FDA
News Digest
May 9,
2005
______________________________________________
IN THIS WEEK'S ISSUE
-- First Whooping Cough Booster Vaccine
Approved for Adolescents
-- Parkinson's Drug Requip Approved to
Treat Restless Legs Syndrome
-- FDA Proposal Would Allow Safety Labeling
in Egg Carton Lids
-- Recalls/Market Withdrawals
--
Congressional Testimony
-- Public Meetings
-- Question
of the Week
___________________________________________________________
First Whooping
Cough Booster Vaccine Approved for Adolescents
FDA has approved
Boostrix, the first vaccine for adolescents that provides booster
immunization against whooping cough (pertussis) in combination with tetanus and
diphtheria. Whooping cough is a highly contagious respiratory disease that can
be serious, possibly fatal, in infants less than one year old. Though the
disease is generally less severe in adolescents, experts feel that immunizing
this group could help prevent transmission of the disease to susceptible
infants.
-- Press
release: http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01354.html
-- Boostrix
approval information: http://www.fda.gov/cber/products/tdapgla050305.htm
Parkinson's Drug
Requip Approved to Treat Restless Legs Syndrome
Requip
(ropinirole), a drug first approved in 1997 for Parkinson's disease, has
received approval as a treatment for moderate-to-severe cases of
restless legs syndrome (RLS). Affecting about 10 percent of the U.S. population,
RLS is characterized by an urge to move the legs, usually accompanied by
uncomfortable leg sensations. Symptoms typically worsen or occur only at night
and can disturb sleep.
http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01356.html
FDA Proposal Would
Allow Safety Labeling in Egg Carton Lids
FDA has proposed a
rule that would allow a safe-handling statement for eggs to be placed inside the
carton lid as long as the statement "Keep Refrigerated" appears on the top or
side panel. The proposal applies to shell eggs that have not been treated to
destroy Salmonella bacteria, which can cause foodborne illness.
Currently, the safe-handling statement must appear on either the top or side
panel of the carton.
-- Press
release: http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01355.html
--
Federal Register notice: http://www.fda.gov/OHRMS/DOCKETS/98fr/05-8907.htm
To view an archive
of past FDA news releases, go to
http://www.fda.gov/opacom/hpnews.html
To access the RSS
feed of FDA news releases, go to
http://www.fda.gov/bbs/topics/news/rssPress.xml
___________________________________________________________
RECALLS/MARKET
WITHDRAWALS
The following
products are being recalled for the reasons shown. Go to the linked pages for
more information.
Edwards Oreo
Singles 2-pack Frozen Pie Slices (undeclared peanuts)
http://www.fda.gov/oc/po/firmrecalls/edwards05_02.html
Asian Taste brand
and Sinbo brand Chinese Red Berry (undeclared sulfites)
http://www.fda.gov/oc/po/firmrecalls/walong05_04.html
ZhenQiWei Dried
Apricots (undeclared sulfites)
http://www.fda.gov/oc/po/firmrecalls/apricots05_05.html
One lot (180
boxes) of Famotidine Injection, 20 mg/2mL (lack of sterility
assurance)
http://www.fda.gov/oc/po/firmrecalls/Amerisource04_05.html
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 Center for
Biologics Evaluation and Research Director Jesse L. Goodman, M.D., before the
House Committee on Energy and Commerce; subject: flu vaccine supply (May
4)
http://www.fda.gov/ola/2005/influenza0504.html
FDA Acting Center
for Drug Evaluation and Research Director
Steven Galson, M.D., before the House Committee on Government Reform;
subject: drug safety (May 5)
http://www.fda.gov/ola/2005/drugsafety0505.html
To view an archive
of FDA congressional testimony, go to
http://www.fda.gov/ola/listing.html
_________________________________________________________
PUBLIC
MEETINGS
May 11 --
Drug Educational
Forum/Public Workshop; will present information about FDA's premarket
requirements to the drug industry, particularly small businesses, startups, and
entrepreneurs (Kansas City, Mo.)
http://www.fda.gov/cder/meeting/de-forum-2005.htm
May 13 --
Anesthesiology and
Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee;
under discussion: FDA's Critical Path initiative; review of postmarket study
design; and pulse oximeters (Gaithersburg, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12624d051305.html
May 17 --
Obstetrics and
Gynecology Devices Panel of the Medical Devices Advisory Committee; under
discussion: a premarket application for a spectroscopy-based cervical imaging
system (Gaithersburg, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12524d051705.htm
May 18-19 --
Drug Safety and
Risk Management Advisory Committee; under discussion: FDA's risk management
program for marketed drugs (Silver Spring, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cder12535dd05181905.html
May 19 --
Antiviral Drugs
Advisory Committee; under discussion: application for approval of a new drug to
treat HIV infection (Gaithersburg, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cder12531d051905.html
For
a list of FDA meetings, seminars, and other public events, go
to
http://www.fda.gov/opacom/hpmeetings.html
_____________________________________________________________
QUESTION OF THE
WEEK
How big is
FDA?
FDA has over 9,000
employees, located in 167 U.S. cities. Among its staff, FDA has chemists,
microbiologists, and other scientists, as well as investigators and inspectors
who visit 16,000 facilities a year as part of their oversight of the businesses
that FDA regulates.
_____________________________________________________________
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