Homeopathic Product Regulation: Evaluating FDA’s Regulatory Framework

Homeopathic Product Regulation: Evaluating FDA’s Regulatory Framework after a Quarter Century

USA : The Food and Drug Administration (FDA) is announcing a public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.

Date : April 20-21, 2015

Time : 9:00 am to 4:00 pm

Location
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503A (Great Room)
Silver Spring, Maryland 20993

Attendance
The public hearing is free and seating will be on a first-come, first-served basis. Individuals that wish to attend should register by submitting electronic requests toCDERHOMEOPATHICPRODUCT@fda.hhs.gov or written requests to Lesley DeRenzo or Cynthia Ng (see “FOR FURTHER INFORMATION CONTACT” section of the Federal Register Notice) by 5 p.m. on April 13, 2015. The request should include the individual’s name, title, business affiliation (if applicable), address, telephone and fax numbers, email address, and type of organization they represent (e.g., industry, consumer organization, etc.). Registrants will receive confirmation once they have been accepted to attend the meeting.

Oral Presentations

If you wish to make an oral presentation during the hearing, you must register by submitting either an electronic or a written request by 5 p.m. on April 13, 2015, to Lesley DeRenzo or Cynthia Ng (see “FOR FURTHER INFORMATION CONTACT” section of the Federal Register Notice). Submit electronic requests toCDERHOMEOPATHICPRODUCT@fda.hhs.gov. You must provide your name, title, business affiliation (if applicable), address, telephone and fax numbers, email address, and type of organization you represent (e.g., industry, consumer organization, etc.). You also should submit a brief summary of the presentation, including the discussion topic(s) that will be addressed and the approximate time requested for your presentation.

Please note that FDA may limit both the number of participants from individual organizations and the total number of attendees based on space limitations.

For more information, please reference section III of the Federal Register Notice

Webcast Information

If you cannot attend in person, information about how you can access a live Webcast will be located at Homeopathic Product Regulation

Agenda

The agenda will be posted soon.

Contact Information

CDERhomeopathicproduct@fda.hhs.gov

Federal Register notification: http://www.gpo.gov/fdsys/pkg/FR-2015-03-27/pdf/2015-07018.pdf

Federal Register notification in html form / print view: https://www.federalregister.gov/articles/2015/03/27/2015-07018/homeopathic-product-regulation-evaluating-the-food-and-drug-administrations-regulatory-framework#print_view