Drugs

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

On April 20-21, 2015, the Food and Drug Administration (FDA) held a public hearing at its White Oak Campus 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 seeks written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA seeks input on a number of specific questions, but is interested in any other pertinent information participants would like to share. Please refer to the following documents for more information:

UPDATE: To allow interested persons additional time to submit comments, on September 9, 2015, FDA re-opened the comment period for the above notice of public hearing for an additional 60 days until November 9, 2015.

Contact Information

CDERhomeopathicproduct@fda.hhs.gov

Agenda

The agenda (PDF - 105KB) for the April 20-21 public hearing is available.

 

Page Last Updated: 09/10/2015
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