Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop, 55405 [05-18871]
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Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Notices
listed in this document have repeatedly
failed to submit reports required by
§ 314.81. In addition, under § 314.200,
we find that the holders of the
applications have waived any
contentions concerning the legal status
of the drug products. Therefore, under
these findings, approval of the
applications listed in this document,
and all amendments and supplements
thereto, is hereby withdrawn, effective
September 21, 2005.
Dated: August 29, 2005.
Steven Galson,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 05–18873 Filed 9–20–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Industry Exchange Workshop on Food
and Drug Administration Clinical Trial
Requirements; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) Dallas District, in
cooperation with the Society of Clinical
Research Associates (SoCRA), is
announcing a workshop on FDA clinical
trial statutory and regulatory
requirements. This 2-day workshop for
the clinical research community targets
sponsors, monitors, clinical
investigators, institutional review
boards, and those who interact with
them for the purpose of conducting
FDA-regulated clinical research. The
workshop will include both industry
and FDA perspectives on proper
conduct of clinical trials regulated by
FDA.
Date and Time: The public workshop
is scheduled for Wednesday, February
8, 2006, from 8:15 a.m. to 5 p.m. and
Thursday, February 9, 2006, from 8:15
a.m. to 4 p.m.
Location: The public workshop will
be held at the Crowne Plaza Hotel
Houston Medical Center, 6701 South
Main, Houston, TX 77030, 713–797–
1110, FAX: 713–796–8291.
Contact: David Arvelo, Food and Drug
Administration, 4040 North Central
Expressway, suite 900, Dallas, TX
75204, 214–253–4952, FAX: 214–253–
4970, e-mail: oraswrsbr@ora.fda.gov.
Registration: Send registration
information (including name, title, firm
name, address, telephone, and fax
number) and the registration fee of $485
SUMMARY:
VerDate Aug<31>2005
14:40 Sep 20, 2005
Jkt 205001
(member), $560 (nonmember), or $460
(government employee nonmember).
(Registration fee for nonmembers
includes a 1-year membership.) The
registration fee for FDA employees is
waived. Make the registration fee
payable to SoCRA, P.O. Box 101,
Furlong, PA 18925. To register via the
Internet go to https://www.socra.org/
html/FDA_Conference.htm (FDA has
verified the Web site address, but is not
responsible for subsequent changes to
the Web site after this document
publishes in the Federal Register). The
registrar will also accept payment by
major credit cards. For more
information on the meeting, or for
questions on registration, contact 800–
SoCRA92 (800–762–7292), or 215–345–
7369, or via e-mail: socramail@aol.com.
Attendees are responsible for their own
accommodations. To make reservations
at the Crowne Plaza Hotel Houston
Medical Center at the reduced
conference rate, contact the Crowne
Plaza Hotel Houston Medical Center
(see Location) before January 17, 2005.
The registration fee will be used to
offset the expenses of hosting the
conference, including meals,
refreshments, meeting rooms, and
materials.
Space is limited, therefore interested
parties are encouraged to register early.
Limited onsite registration may be
available. Please arrive early to ensure
prompt registration. If you need special
accommodations due to a disability,
please contact David Arvelo (see
Contact) at least 7 days in advance of
the workshop.
SUPPLEMENTARY INFORMATION: The
workshop on FDA clinical trials
statutory and regulatory requirements,
helps fulfill the Department of Health
and Human Services and FDA’s
important mission to protect the public
health by educating researchers on
proper conduct of clinical trials. Topics
for discussion include the following: (1)
FDA regulation of the conduct of
clinical research; (2) medical device,
drug, and biological product aspects of
clinical research; (3) investigator
initiated research; (4) pre-investigational
new drug application meetings and FDA
meeting process; (5) informed consent
requirements; (6) ethics in subject
enrollment; (7) FDA regulation of
institutional review boards; (8)
electronic records requirements; (9)
adverse event reporting; (10) how FDA
conducts bioresearch inspections; and
(11) what happens after the FDA
inspection. FDA has made education of
the research community a high priority
to ensure the quality of clinical data and
protect research subjects. The workshop
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
55405
helps to implement the objectives of
section 406 of the FDA Modernization
Act (21 U.S.C. 393) and the FDA Plan
for Statutory Compliance, which
includes working more closely with
stakeholders and ensuring access to
needed scientific and technical
expertise. The workshop also furthers
the goals of the Small Business
Regulatory Enforcement Fairness Act
(Public Law 104–121) by providing
outreach activities by Government
agencies directed to small businesses.
Dated: September 15, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–18871 Filed 9–20–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Psychopharmacologic 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:
Psychopharmacologic 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 October 25, 2005, from 8 a.m.
to 5 p.m. and on October 26, 2005, from
8 a.m. to 3 p.m.
Location: Hilton, The Ballrooms, 620
Perry Pkwy., Gaithersburg, MD. The
hotel phone number is 301–977–8900.
Contact Person: Karen TempletonSomers, Center for Drug Evaluation and
Research (HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
7001, FAX: 301–827–6776, e-mail:
somersk@cder.fda.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512544. Please call the Information
Line for up-to-date information on this
meeting. The background material will
become available no later than the day
before the meeting and will be posted
on FDA’s Web site at https://
E:\FR\FM\21SEN1.SGM
21SEN1
]]>Agencies
[Federal Register Volume 70, Number 182 (Wednesday, September 21, 2005)]
[Notices]
[Page 55405]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18871]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Industry Exchange Workshop on Food and Drug Administration
Clinical Trial Requirements; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) Dallas District, in
cooperation with the Society of Clinical Research Associates (SoCRA),
is announcing a workshop on FDA clinical trial statutory and regulatory
requirements. This 2-day workshop for the clinical research community
targets sponsors, monitors, clinical investigators, institutional
review boards, and those who interact with them for the purpose of
conducting FDA-regulated clinical research. The workshop will include
both industry and FDA perspectives on proper conduct of clinical trials
regulated by FDA.
Date and Time: The public workshop is scheduled for Wednesday,
February 8, 2006, from 8:15 a.m. to 5 p.m. and Thursday, February 9,
2006, from 8:15 a.m. to 4 p.m.
Location: The public workshop will be held at the Crowne Plaza
Hotel Houston Medical Center, 6701 South Main, Houston, TX 77030, 713-
797-1110, FAX: 713-796-8291.
Contact: David Arvelo, Food and Drug Administration, 4040 North
Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX:
214-253-4970, e-mail: oraswrsbr@ora.fda.gov.
Registration: Send registration information (including name, title,
firm name, address, telephone, and fax number) and the registration fee
of $485 (member), $560 (nonmember), or $460 (government employee
nonmember). (Registration fee for nonmembers includes a 1-year
membership.) The registration fee for FDA employees is waived. Make the
registration fee payable to SoCRA, P.O. Box 101, Furlong, PA 18925. To
register via the Internet go to https://www.socra.org/html/FDA_
Conference.htm (FDA has verified the Web site address, but is not
responsible for subsequent changes to the Web site after this document
publishes in the Federal Register). The registrar will also accept
payment by major credit cards. For more information on the meeting, or
for questions on registration, contact 800-SoCRA92 (800-762-7292), or
215-345-7369, or via e-mail: socramail@aol.com. Attendees are
responsible for their own accommodations. To make reservations at the
Crowne Plaza Hotel Houston Medical Center at the reduced conference
rate, contact the Crowne Plaza Hotel Houston Medical Center (see
Location) before January 17, 2005. The registration fee will be used to
offset the expenses of hosting the conference, including meals,
refreshments, meeting rooms, and materials.
Space is limited, therefore interested parties are encouraged to
register early. Limited onsite registration may be available. Please
arrive early to ensure prompt registration. If you need special
accommodations due to a disability, please contact David Arvelo (see
Contact) at least 7 days in advance of the workshop.
SUPPLEMENTARY INFORMATION: The workshop on FDA clinical trials
statutory and regulatory requirements, helps fulfill the Department of
Health and Human Services and FDA's important mission to protect the
public health by educating researchers on proper conduct of clinical
trials. Topics for discussion include the following: (1) FDA regulation
of the conduct of clinical research; (2) medical device, drug, and
biological product aspects of clinical research; (3) investigator
initiated research; (4) pre-investigational new drug application
meetings and FDA meeting process; (5) informed consent requirements;
(6) ethics in subject enrollment; (7) FDA regulation of institutional
review boards; (8) electronic records requirements; (9) adverse event
reporting; (10) how FDA conducts bioresearch inspections; and (11) what
happens after the FDA inspection. FDA has made education of the
research community a high priority to ensure the quality of clinical
data and protect research subjects. The workshop helps to implement the
objectives of section 406 of the FDA Modernization Act (21 U.S.C. 393)
and the FDA Plan for Statutory Compliance, which includes working more
closely with stakeholders and ensuring access to needed scientific and
technical expertise. The workshop also furthers the goals of the Small
Business Regulatory Enforcement Fairness Act (Public Law 104-121) by
providing outreach activities by Government agencies directed to small
businesses.
Dated: September 15, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-18871 Filed 9-20-05; 8:45 am]
BILLING CODE 4160-01-S
