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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.

PDF requires the free Adobe Acrobat Reader

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Date created: February 9, 2005, updated June 3, 2005

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