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Industry News
October 3, - October 9, 2005
October 7th:Cellular Phones Interfere With
Devices, Says Study
Electromagnetic interference from
cell phones interferes with devices, according to a study by the
Mayo Clinic.
The study found that 44 percent of
the devices tested had some instance of electromagnetic interference
(EMI) from cell phones. The scientists tested 16 different devices
with six cell phones to assess the potential for EMI, finding EMI in
seven of the devices. However, of the 510 tests performed, the
incidence of clinically important interference was only 1.2 percent.
EMI was induced in 108 of those tests, or 21.2 percent of the tests
done.
Public Interest
Groups Wary Of FDA's Risk-Based Assessment System
Public interest groups are concerned that an FDA initiative to use
risk-based reviews to speed drug approvals could cause more problems
than it solves.
The agency recently announced the establishment of the Office of New
Drug Quality Assessment (ONDQA) to facilitate the implementation of
a modern, risk-based pharmaceutical quality assessment system (PQAS).
ONDQA, which becomes effective Nov. 1 under the auspices of the
Office of New Drug Chemistry, will be charged with several goals,
the biggest of which is balancing the need for faster drug approvals
with the rapid introduction of new technologies into pharmaceutical
manufacturing.
The PQAS will replace the FDA's current chemistry, manufacturing and
controls (CMC) review system, which the agency said may be slowing
manufacturers' adoption of new technologies. Under the CMC review
system, drugmakers must seek FDA approval through a supplement
before implementing postmarketing manufacturing changes.
October 6th:
FDA Warns Tyco Over Device
Production
The FDA recently warned Tyco
International about the company's failure to quickly tell the agency
about possible problems with certain devices.
In a recent warning letter, the FDA
chided Tyco for failing to submit Medical Device Reporting reports
within 30 days of becoming aware that some of its devices may have
caused or contributed to a death or serious injury. The letter, made
public Oct. 3, also argues that the company did not maintain
distribution records for its devices, ensure that these products
followed design specifications, or properly review complaints about
some products.
Clinical Trials
Portal Launched By IFPMAThe International Federation of Pharmaceutical Manufacturers and
Associations (IFPMA) has launched an Internet search portal that
provides a centralized location to access clinical trial registries
and databases worldwide.
The IFPMA Clinical Trials Portal is the first Internet search engine
constructed specifically to link to online information made
available by the pharmaceutical industry about clinical trials
worldwide, the trade group said. Developed in conjunction with IBM,
the website currently contains more that 250,000 links to clinical
trial-related information. The group announced in May it was
developing the portal.
The website provides access to a wide array of resources, including
individual pharmaceutical company sites, sites run by third parties
working on behalf of these companies, pharmaceutical industry
association resources and government sites such as the National
Library of Medicine's www.clinicaltrials.gov. Other online clinical
trial information resources, such as the European Union's planned
Europharm facility, may be linked to the site as they become
available, IFPMA said.
FDA Approves
Lipitor To Prevent Heart Attack, Stroke In TYPE 2 DiabeticsThe FDA has approved Pfizer's cholesterol-lowering drug Lipitor as a
treatment to reduce the risk of stroke and heart attack in diabetic
patients, expanding the potential patient population for what is
already the world's top-selling pharmaceutical product.
The expanded indication for Lipitor (atorvastatin calcium) applies
to Type 2 diabetics who have no evidence of heart disease but
present other risk factors, such as high cholesterol, high blood
pressure, smoking, obesity or a family history of cardiovascular
problems.
The new indication was based on the findings of the Collaborative
Atorvastatin Diabetes Study (CARDS), a 2,800-subject study that
showed patients taking Lipitor experienced nearly 50 percent fewer
strokes than those taking placebo.
Drug-Coated Stents Better For
Diabetics
Drug-coated stents are better for
diabetic patients than bare metal stents, a recent study finds.
According to results published in the Oct. 4 issue of Circulation,
diabetics who used bare metal stents had a significantly higher rate
of artery-narrowing than patients using drug-eluting stents (DES).
The study included 160 people with
diabetes, half of whom used bare metal stents after angioplasty. The
other half used stents coated with the drug sirolimus. In the nine
months following the procedure, the arteries of patients given DES
narrowed by an average of 0.06 mm, while the arteries of patients
using bare metal stents narrowed by an average of 0.47 mm.
This difference had a significant
effect on patients' health, the study found. While 29 of the 80
patients who got the bare metal stents died or experienced adverse
events such as heart attacks, only eight of the 80 patients who
received DES had such problems. Also, while 25 of the patients with
the bare metal stents needed repeat angioplasty, only five of the
patients with DES needed a repeat procedure.
Scientists Developing 12-Year
Device Batteries
Scientists at the University of
Wisconsin-Madison are developing supercharged lithium batteries that
would last 12 years, twice as long as current device batteries.
These new batteries would use
organosilicon compounds to last longer, said Robert West, the
school's professor emeritus of chemistry. "If you're going to
implant these things, you want a [battery] lifetime of at least 10
years," he noted. The batteries would also be able to accept a
charge from outside the body without the need for surgery.
Eschenbach Will
Head FDA, Continue As NCI DirectorAndrew von Eschenbach will continue to be director of the National
Cancer Institute, but will turn over day-to-day decisionmaking to a
subordinate while serving as interim FDA commissioner, agency
spokespeople say. The decision, while addressing some critics'
concerns with Eschenbach, may delay selection of a permanent FDA
chief, industry sources say.
Eschenbach announced in a recent memo to staff at both agencies that
John Niederhuber would take over as NCI's chief operating officer
while he runs the FDA. The transition will "ensure that the
important work of the NCI moves forward," Eschenbach said, adding
that he is "now devoting my energies to the work of the FDA in
protecting and advancing the health of the American people."
Niederhuber is the former chair of the National Cancer Advisory
Board.
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