Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting, 15866 [05-6087]
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15866
Federal Register / Vol. 70, No. 59 / Tuesday, March 29, 2005 / Notices
manufacturer, and indications to be
studied under the referrals (21 U.S.C.
355a(d)(4)(B)(ii)).
In accordance with section 4 of the
BPCA, FDA is announcing that it has
referred to the Foundation the written
requests for pediatric studies for
KEMSTRO (baclofen) and DROXIA
(hydroxyurea). On April 30, 2004, FDA
issued a written request for pediatric
studies to Schwarz Pharma, Inc., the
holder of approved applications for
KEMSTRO (baclofen) that have market
exclusivity. The studies described in the
written request were for the treatment of
spasticity in the pediatric population.
Schwarz Pharma, Inc., declined to
conduct the requested studies. FDA has
determined that there is a continuing
need for information relating to the use
of KEMSTRO (baclofen) in the pediatric
population.
On March 29, 2004, FDA issued a
written request for pediatric studies to
Bristol-Myers Squibb Co., the holder of
approved applications for DROXIA
(hydroxyurea) that have market
exclusivity. The studies described in the
written request were for the treatment of
sickle cell disease in the pediatric
population. Bristol-Myers Squibb Co.
declined to conduct the requested
studies. FDA has determined that there
is a continuing need for information
relating to the use of DROXIA
(hydroxyruea) in the pediatric
population.
Consistent with the provisions of the
BPCA, FDA referred to the Foundation
the written requests for the conduct of
the pediatric studies for KEMSTRO
(baclofen) on September 1, 2004, and
DROXIA (hydroxyurea) on October 20,
2004.
Dated: March 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–6158 Filed 3–28–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Pulmonary-Allergy Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
VerDate jul<14>2003
17:01 Mar 28, 2005
Jkt 205001
Name of Committee: PulmonaryAllergy Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on June 6, 2005, from 8 a.m. to 5:30
p.m.
Location: Center for Drug Evaluation
and Research Advisory Committee
Conference Room, rm. 1066, 5630
Fishers Lane, Rockville, MD.
Contact Person: Teresa A. Watkins,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5630 Fishers Lane, rm.
1093, Rockville, MD 20857, 301–827–
7001, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512545. Please call the
Information Line for up-to-date
information on this meeting.
Agenda: The committee will consider
the safety and efficacy of new drug
application (NDA) 50–799, proposed
trade name PULMINIQ (cyclosporine,
inhalation solution) Chiron Corp., for
use in combination with standard
immunosuppressive therapy to increase
survival and prevent chronic rejection
in patients receiving allogenic lung
transplants.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person by May 26, 2005. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before May 26, 2005, and submit
a brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact La’Nise Giles
at 301–827–7001 at least 7 days in
advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Dated: March 21, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–6087 Filed 3–28–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2004D–0187, 2004D–0188, and
2004D–0189]
Guidances for Industry on
Premarketing Risk Assessment;
Development and Use of Risk
Minimization Action Plans; and Good
Pharmacovigilance Practices and
Pharmacoepidemiologic Assessment;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of three guidances for
industry entitled ‘‘Premarketing Risk
Assessment,’’ ‘‘Development and Use of
Risk Minimization Action Plans,’’ and
‘‘Good Pharmacovigilance Practices and
Pharmacoepidemiologic Assessment.’’
These guidances provide guidance to
industry on risk management activities
for drug products, including biological
drug products, in the Center for Drug
Evaluation and Research (CDER) and the
Center for Biologics Evaluation and
Research (CBER). The guidances
address, respectively, premarket risk
assessment; the development,
implementation, and evaluation of risk
minimization action plans for drug
products; and good pharmacovigilance
practices and pharmacoepidemiologic
assessment of observational data.
DATES: Submit written or electronic
comments on agency guidances at any
time.
Submit written requests for
single copies of the guidances to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, or the Office of
Communication, Training and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448. These
guidances may also be obtained by mail
by calling CBER at 1–800–4709 or 301–
827–1800. Send three self-addressed
ADDRESSES:
E:\FR\FM\29MRN1.SGM
29MRN1
]]>Agencies
[Federal Register Volume 70, Number 59 (Tuesday, March 29, 2005)]
[Notices]
[Page 15866]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6087]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Pulmonary-Allergy Drugs Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on June 6, 2005, from 8
a.m. to 5:30 p.m.
Location: Center for Drug Evaluation and Research Advisory
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
Contact Person: Teresa A. Watkins, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5630 Fishers Lane, rm.
1093, Rockville, MD 20857, 301-827-7001, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 3014512545. Please call the Information Line for up-to-date
information on this meeting.
Agenda: The committee will consider the safety and efficacy of new
drug application (NDA) 50-799, proposed trade name PULMINIQ
(cyclosporine, inhalation solution) Chiron Corp., for use in
combination with standard immunosuppressive therapy to increase
survival and prevent chronic rejection in patients receiving allogenic
lung transplants.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person by May 26, 2005.
Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before May 26, 2005, and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their
presentation.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact La'Nise Giles at
301-827-7001 at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: March 21, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-6087 Filed 3-28-05; 8:45 am]
BILLING CODE 4160-01-S
