FDA News Digest
September
5,
2006
________________________________________________________
IN THIS WEEK'S
ISSUE
» News
-- First Generic Versions
of Injected Antibiotic Ciprofloxacin
Approved
--
FDA Approves First
Totally Implanted Artificial Heart for Critically
Ill
--
FDA Warns Not to Buy Rx
Drugs from Certain Canadian Web
Sites
--
Task Force Created
to Review Safety of Human Cells and Tissue
--
FDA to Review Rules
Allowing Research Without Informed
Consent
»
Recalls/Safety
Alerts
»
Upcoming Public
Meetings
» Question of
the Week
____________________________________________
NEWS
First Generic Versions
of Injected Antibiotic Ciprofloxacin
Approved
FDA has approved the
first generic versions of Cipro I.V. (ciprofloxacin injection), an antibiotic
used to treat a variety of bacterial infections, including those of the
respiratory system, urinary tract, bones, joints, and skin. Using
generic versions of Cipro can result in significant savings for the
millions of Americans with bacterial infections, FDA
says.
FDA Approves
First Totally Implanted Artificial Heart for Critically
Ill
FDA has approved the
AbioCor Implantable Replacement Heart, the first totally implanted artificial
heart for patients with advanced heart failure involving both chambers of the
heart. The device is intended for people not eligible for a heart transplant and
who are unlikely to live more than a month without
intervention.
FDA Warns Not to
Buy Rx Drugs from Certain Canadian Web Sites
Consumers shouldn't buy
or use prescription drugs from websites that have orders filled by Manitoba,
Canada-based Mediplan Prescription Plus Pharmacy or Mediplan Global Health, FDA
warns. The agency has received reports that these companies are selling
counterfeit versions of 10 drug products, including Lipitor, Actonel, Nexium,
and Propecia.
Task Force
Created to Review Safety of Human Cells and Tissue
FDA has formed a
multidisciplinary task force to help strengthen the agency's system for
regulating human cells and tissue. The task force will identify whether
additional changes are needed to bolster
the required practices designed
to prevent transmission of communicable
diseases.
FDA to Review
Rules Allowing Research Without Informed
Consent
FDA is examining the
implementation of a 1996 regulation that provides a narrow exception to
established requirements for informed consent by participants in medical
research. The regulation allows conduct of research studies to test emergency
treatments on patients with certain life-threatening conditions (head trauma,
cardiac arrest, stroke) when patients or family cannot give informed consent.
FDA says it is reviewing the regulation "to make sure that emergency
research is being carried out in a scientifically sound and ethical
manner."
To
view an archive of past FDA news releases, go to
RECALLS/SAFETY
ALERTS
Food Recalls:
Certain lots of Kinney brand water, all
sizes
Reason for recall: bromate levels may exceed federal
standards
For a
list of recalls, market withdrawals, and safety alerts involving
FDA-regulated
products
from the past 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
[What is
an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
_____________________________________________
UPCOMING PUBLIC MEETINGS
Sept. 6-7 -- Joint meeting of
Dental Products Panel of the Medical Devices Advisory Committee and the
Peripheral and Central Nervous System Drugs Advisory
Committee
Under discussion: dental amalgam
devices
Location: Gaithersburg,
Md.
http://www.fda.gov/oc/advisory/accalendar/2006/cdrh12518dd09060706.html
Sept. 12 --
FDA Animal Feed Safety System Public
Meeting
Under
discussion: a method for ranking animal feed contaminants by their relative
risks
Location: Rockville, Md.
http://www.fda.gov/cvm/AFSS092006PM.htm
Sept. 25 --
Veterinary Medicine Advisory Committee Fall 2006
Meeting
Under
discussion: the microbial food safety of an antimicrobial drug application
currently under review for use in food-producing
animals
Location: Rockville, Md.
http://www.fda.gov/cvm/VMAC/VMACFall2006.htm
Sept. 26 -- Risk
Communication on Medical Devices: Sharing Perspectives
Under discussion: how the
government and device industry communicate expected and unexpected risks to
doctors, patients and the public
Location: North Bethesda, Md.
http://www.fda.gov/cdrh/meetings/092606-riskcommunication.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
What is cardiovascular
disease?
Cardiovascular disease (CVD) is
not one single disease or condition. It is a group of different disorders that
affect your heart and blood vessels. Some types of CVD occur from birth, and
others are developed over a lifetime.
To learn more about specific
cardiovascular conditions and diseases go to the following links:
-- Angina (chest
pain)
http://www.fda.gov/hearthealth/conditions/angina.html
-- Atherosclerosis (hardening of
the arteries)
http://www.fda.gov/hearthealth/conditions/atherosclerosis.html
-- Congestive heart
failure
http://www.fda.gov/hearthealth/conditions/congestiveheartfailure.html
-- Coronary artery
disease
http://www.fda.gov/hearthealth/conditions/coronaryarterydisease.html
-- Heart
attack
http://www.fda.gov/hearthealth/conditions/heartattack.html
__________________________________________________
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