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Public
Workshop
May 11, 2005
Drug Educational Forum
The FDA Center for Drug Evaluation and Research (CDER), in
collaboration with FDA's Office of Regulatory Affairs (ORA),
Southwest Regional Office (SWRO), is announcing a public workshop
entitled "FDA Drug Educational Forum". This public workshop is
intended to provide information about FDA's premarket requirements
to the drug industry, particularly small businesses, startups, and
entrepreneurs. Federal Register Notice: [Text]
or [PDF].
Notice of Public Workshop; correction. [TXT]
[PDF]
Date and Time: May 11, 2005, from 8 a.m. to 5 p.m.
Agenda
Presentations (6/3/2005)
- Drug Educational Forum [PDF]
- Introduction [PPT],
John A. Friel, J.D., CDER
- Planning for Successful, Efficient, Pharmaceutical Product
Development [PPT],
Kim Colangelo, CDER
- Current Challenges and Concerns for ANDAs [PPT],
Martin H. Shimer, CDER
- OTC 101 [PPT],
David Hilfiker, CDER
- The Basics of CMC [PPT],
Ramnarayan Randad, Ph. D., CDER
- System Inspections [PPT]
- Mastering Regulatory Compliance [PPT],
Thomas J. Arista, ORA
- Financial Assistance and Incentives for Research and
Development of New Drug/Biologic Products [PPT],
Ron Wilson, CDER
- ORA Small Business Representative [PPT],
David Arvelo, ORA
Location: Kansas City Health Department Auditorium, 2400
Troost Ave., Kansas City, MO 64108-2666. For directions to the
facility, please: Visit
http://www.kcmo.org/health.nsf/web/healthmap?opendocument
Email: health@kcmo.org
Phone: 816-513-6008
Contact: David Arvelo (FDA Small Business
Representative) or Cassandra Davis (FDA Small Business Technician)
Email:
oraswrsbr@ora.fda.gov
FAX: 214-253-4970
Mail: Food and Drug Administration, 4040 N. Central
Expressway, Suite 900, Dallas, TX 75204-3128
Phone: 214-253-4952 or 214-253-4951
Registration: Registration begins on April 6, 2005, and ends
May 6, 2005. Registration is free. Seats are limited, please
register as soon as possible. Space will be filled in order of
receipt of registration. Those registered will receive
confirmation. Registration will close after available space fills.
Registration at the site will be based on space availability on
the day of the event starting at 8 a.m.
If you need special accommodations due to disability, please
contact David Arvelo or Cassandra Davis at the contact information
stated above at least 7 days in advance.
Registration Form Instructions: To register,
complete the following
registration form and submit via:
E-mail:
oraswrsbr@ora.fda.gov,
FAX: 214-253-4970, or
Mail to: Food and Drug Administration, Southwest Regional
Office, Small Business Representative, 4040 N. Central Expressway,
suite 900, Dallas, TX 75204-3128.
Supplementary Information: The public workshop is being held in
response to the interest in the topics discussed from small drug
manufacturers, startups, and entrepreneurs in the FDA Southwest
Region area. FDA, CDER, and ORA present this public workshop to
help achieve objectives set forth in section 406 of the Food and
Drug Administration Modernization Act of 1997 (21 U.S.C. 393),
which include working closely with stakeholders and maximizing the
availability and clarity of information to stakeholders and the
public. This is also consistent with the purposes of FDA's
Regional Small Business Program, which are in part to respond to
industry inquiries, develop educational materials, sponsor
workshops and conferences to provide firms, particularly small
businesses, with firsthand working knowledge of FDA's requirements
and compliance policies. This public workshop is also consistent
with the Small Business Regulatory Enforcement Fairness Act of
1996 (Public Law 104-121), as outreach activities by Government
agencies to small businesses.
The goal of the public workshop is to present information that
will enable manufacturers and regulated industry to better comply
with the new drug approval process (21 CFR part 314). Information
presented will be based on agency position as articulated through
regulation, compliance policy guides, and information previously
made available to the public. Topics to be discussed at the public
workshop include the following:
(1) Planning for successful, efficient, pharmaceutical product
approval;
(2) current challenges and concerns for generic abbreviated new
drug applications (ANDA's);
(3) regulatory aspects and challenges in the development of
over-the-counter (OTC) Drugs;
(4) the basics of chemistry, manufacturing and control;
(5) FDA 483 issues;
(6) mastering regulatory compliance; and
(7) incentives for small businesses.
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Date created: February 9, 2005, updated June 3,
2005 |
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