Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Examination Of Homeopathic Regulation Looks Beyond Safety History

This article was originally published in The Tan Sheet

Executive Summary

CDER Director Janet Woodcock says the current regulatory framework limits FDA’s direct regulation of homeopathics to post-market surveillance. During a two-day public hearing, agency officials question stakeholders about trials, labeling and how well consumers understand their products.

You may also be interested in...



King Bio Tops List Of Homeopathic Firms FDA Warns In Show Of Enforcement

FDA warns King Bio, three other homeopathic product marketers. In addition to GMP deficiencies, "we continue to see products labeled as homeopathic that are being marketed without approval for a wide array of diseases and conditions, from chronic pain to cancer,” says FDA Commissioner Gottlieb.

FDA 'Evolving' Homeopathic Drug Enforcement With Risk-Based Approach

Problems stated in a draft guidance where FDA will "prioritize enforcement and regulatory actions" includes products with routes of administration other than oral and topical or intended to be used for the prevention or treatment of serious or life-threatening diseases and conditions.

US FDA Moves Homeopathic Drug Enforcement To Risk-Based Approach

Products with routes of administration other than oral and topical or intended to be used for the prevention or treatment of serious or life-threatening diseases and conditions will be among those prioritized for enforcement and "regulatory actions," draft guidance notes.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS107626

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel