U.S. FDA advisory meetings through June 29

THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION
UPDATES ITS SCHEDULE. ALL ITEMS EST/GMT UNTIL MARCH 13 WHEN
TIMES ARE EDT/GMT.

For more information on the FDA’s Advisory Committee
meetings, see:
http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm
(Expands March 17-18 tobacco products meeting, adds April 12
cancer drugs meeting)

PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE

DATE: March 8, 0800/1300

LOCATION: FDA White Oak Campus, 10903 New Hampshire Ave.,
Building 31, Silver Spring, Md.

CONTACT: Kristine Khuc, 301-796-9001

The committee will discuss Novartis AG’s (NOVN.VX: Quote, Profile, Research) (NVS.N: Quote, Profile, Research)
new drug application for its Arcapta Neohaler, also known by
its chemical name indacaterol maleate, for the long-term,
once-daily maintenance bronchodilator treatment of airflow
obstruction in patients with chronic obstructive pulmonary
disease (COPD), including chronic bronchitis and/or emphysema.

MOLECULAR AND CLINICAL GENETICS PANEL OF THE MEDICAL
DEVICES ADVISORY COMMITTEE

DATE: March 8-9, 0800/1300

LOCATION: Holiday Inn, 2 Montgomery Village Ave.,
Gaithersburg, Md.

CONTACT: James Swink, 301-796-6313

The committee will discuss and make recommendations on
scientific issues concerning direct-to-consumer (DTC) genetic
tests that make medical claims.

The scientific issues to be discussed include:

1) The risks and benefits of making clinical genetic tests
available for direct access by a consumer without a
prescription

The discussion will include consideration of the benefits
and risks of direct access for different tests or categories of
tests that would support differences in the regulatory
approach. Clinical genetic test categories that have been
proposed to be offered directly to consumers include genetic
carrier screening for hereditary diseases (e.g., cystic
fibrosis carrier screening);genetic tests to predict risk for
future development of disease in currently healthy people
(e.g., tests to predict risk of developing breast or ovarian
cancer); and genetic tests for treatment response prediction
(e.g., tests to predict whether an individual will respond to a
specific drug)

2) The risks of and possible mitigations for incorrect,
miscommunicated or misunderstood test results for clinical
genetic tests that might be beneficial if offered through
direct access testing

3) The level and type of scientific evidence appropriate
for supporting direct-to-consumer genetic testing claims
including whether it should be different than that required to
support similar claims for prescription use of clinical genetic
tests.

ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEE

DATE: March 10, 0800/1300

LOCATION: FDA White Oak Campus, 10903 New Hampshire Ave.,
Building 31, Silver Spring, Md.

CONTACT: Kalyani Bhatt, 301-796-9001

The committee will receive updates about findings related
to degeneration in the nervous system in juvenile animals
exposed to anesthetic drugs, as well as results from human
epidemiological studies using anesthesia in children; discuss
the findings’ relevance to pediatric patients and provide
guidance for future studies; and discuss the potential
implications of these data upon the practice of pediatric
anesthesia as well as the communication of the risk of
sedative/anesthetic agents to prescribers and parents.

PERIPHERAL AND CENTRAL NERVOUS SYSTEM DRUGS ADVISORY
COMMITTEE

DATE: March 10, 0800/1300

LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.

CONTACT: Diem-Kieu Ngo, 301-796-9001

The committee will discuss, in general, the use of
historical-controlled trials for the approval of anticonvulsant
monotherapy for seizures of partial origin for antiepileptic
drug products that are already approved for adjunctive therapy.
It will also discuss how this may specifically apply to the
approval of GlaxoSmithKline’s supplemental new drug application
to market its Lamictal XR for patients 13 years of age and
older with partial seizures who are receiving therapy with a
single antiepileptic drug.

**UPDATES TO ADD NOV. 18**

TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE

DATE: March 17-18, 0800/1200

LOCATION: FDA White Oak Conference Center, Building 31
Conference Center, the Great Room (room 1503), 10903 New
Hampshire Ave., Silver Spring, Md.

CONTACT: Caryn Cohen, 301-443-0572

The committee will continue to receive updates from the
Menthol Report Subcommittee and discuss plans for finalizing
the report regarding the impact of use of menthol in cigarettes
on the public health.

NOTE: On March 18, the committee will meet for a half-day
session ending at noon.

NEUROLOGICAL DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY
COMMITTEE

DATE: March 17-18, 0800/1200

LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.

CONTACT: Olga Claudio, 301-796-7608

On March 17, the committee will discuss, make
recommendations and vote on information related to the
premarket approval application for the NovoTTF-100A Treatment
Kit, sponsored by Hogan Lovells US LLP for NovoCure, Ltd. The
NovoTTF-100A Treatment Kit is intended as a treatment for
adults older than 21 years of age with histologically- or
radiologically-confirmed glioblastoma multiforme (GBM),
following recurrence in the supra-tentorial region of the
brain. The device is intended to be used as a monotherapy,
after surgical and radiation options have been exhausted, in
place of standard medical therapy for GBM.

On March 18, the committee will discuss, make
recommendations and vote on information related to Covidien’s
(COV.N: Quote, Profile, Research) application for the Pipeline Embolization Device (PED).
The PED is indicated for the endovascular treatment of large or
giant wide-necked intracranial aneurysms in the paraclinoid
region of the internal carotid artery.

FOOD ADVISORY COMMITTEE

DATE: March 30 and 31, 0830/1230

LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.

CONTACT: Carolyn Jeletic, 301-436-1913

The committee will discuss whether available relevant data
demonstrate a link between children’s consumption of synthetic
color additives in food and adverse effects on behavior.

ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE

DATE: April 5, 0830/1230

LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.

CONTACT: Minh Doan, 301-796-9001

The committee will discuss a new drug application from
Optimer Pharmaceuticals Inc (OPTR.O: Quote, Profile, Research) for fidaxomicin tablets
for the requested indication of treatment of adults with
Clostridium difficile infection (CDI), also known as
Clostridium difficile-associated diarrhea (CDAD), and
prevention of recurrences.

ONCOLOGIC DRUGS ADVISORY COMMITTEE

DATE: April 12, 0800/1200

LOCATION: FDA White Oak Campus, 10903 New Hampshire Ave.,
Building 31 Conference Center, Silver Spring, Md.

CONTACT: Caleb Briggs, 301-796-9001

During the morning session, the committee will discuss a
supplemental new drug application from Novartis for Afinitor.
The proposed use is for the treatment of patients with advanced
neuroendocrine tumors (NET) of gastrointestinal, lung, or
pancreatic origin.

During the afternoon session, the committee will discuss a
supplemental application from Pfizer Inc (PFE.N: Quote, Profile, Research) for Sutent.
The proposed use for this product is for the treatment of
unresectable pancreatic neuroendocrine tumors (PNET).

ONCOLOGIC DRUGS ADVISORY COMMITTEE

DATE: June 28-29, time TBD

LOCATION: TBD

CONTACT: TBD

The committee will review issues involved with the FDA’s
recommendation that Roche Holding AG (ROG.VX: Quote, Profile, Research) Genentech unit’s
cancer drug Avastin no longer be marketed for use in breast
cancer patients.
(Reporting by Lisa Richwine and Susan Heavey; Editing by Tim
Dobbyn)