News: July 31, 2007

FDA Commissioner Endorses Task Force Report on Nanotechnology. FDA's
Nanotechnology Task Force released a report on July 25th recommending
that the agency develop guidance for manufacturers and researchers that
would clarify what information to give FDA about products and when the
use of nanoscale materials might change the regulatory status of a
product. The task force also recommended that FDA should (1) work to
assess data needs to better regulate these products, including attention
to the biological effects and interactions of materials; (2) develop
in-house expertise; (3) ensure consideration of new information as it
emerges; and (4) evaluate the adequacy of currently required testing
approaches to assessing safety, effectiveness, and quality of nanoscale
materials. The task force noted that while nanoscale materials present
challenges similar to products using other emerging technologies, that
this picture is complicated by the fact that properties relevant to
product safety and effectiveness may change as size of material varies
within the nanoscale. Additional information is available at
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01671.html.

The task force report may be viewed at
http://www.fda.gov/nanotechnology/taskforce/report2007.html.

Senate Subcommittee on Retirement and Aging hears from FDA Commissioner
About Alzheimer-specific Product Development Within the Agency. The
Commissioner told the subcommittee about a collaborative study on an
automated cognitive assessment of persons with and without Alzheimer's
disease. The study was conducted by FDA scientists from the National
Center for Toxicological Research and non-agency scientists. They
studied performance on behavioral test tasks that measure timing
perception ability, short-term memory, and learning ability using an
automated system called the NCTR Operant Test Battery (OTB). Subjects
with Alzheimer's disease were less accurate in the time perception and
short term memory tasks and were rarely responsive in the learning task.
The OTB can differentiate between normal controls and persons with
Alzheimer's disease, and may provide reliable, objective measures useful
for longitudinal monitoring of status and treatment effectiveness. A
report on this study is in preparation. Additional information is
available at http://www.fda.gov/ola/2007/alzheimersdisease071707.html.

FDA Issues Revised Draft Guidance for In Vitro Diagnostic Multivariate
Index Assays (IVDMIAs). The agency published a Federal Register notice
on July 26th indicating the availability of a revised draft guidance
concerning IVDMIAs. The agency intends to terminate enforcement
discretion for the subclass of laboratory developed tests (LDTs) known
as IVDMIAs because of concerns that patients and healthcare
practitioners rely on IVDMIAs with high risk intended uses to make
critical healthcare decisions when there is no independent assurance
that these assays have been properly clinically validated, and without
ability to determine whether the tests give clinically valid results.
More information is available at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm.

The draft guidance document may be viewed at
http://www.fda.gov/cdrh/oivd/guidance/1610.html.

Circulatory System Devices Panel of the Medical Devices Advisory
Committee To Meet. The agency announced, on July 27th, that the
advisory committee will meet in September to provide advice and
recommendations to FDA on regulatory issues. On September 19th , the
committee will discuss, make recommendations and vote on a premarket
approval application, sponsored by SyntheMed, Inc., for the REPEL-CV,
which is a surgical adjuvant indicated for reducing the incidence,
severity and extent of post-operative adhesion formation in patients
undergoing cardiac surgery. On September 20th, the committee will
discuss and make recommendations regarding clinical trial designs for
cardiac ablation devices designed to treat patients with medically
refractory atrial fibrillation. More information is available at
http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-14600.htm.