Traditional medicine
This article was originally published in The Tan Sheet
Executive Summary
The Traditional Medicines Congress has released a first draft of its detailed model on how to regulate traditional medicines in the U.S., the American Herbal Products Association announces Nov. 29. The 16-page document, "A Proposed Regulatory Model for Traditional Medicines: Guiding Assumptions and Key Components," was published by the nine member organizations of the TM Congress, which formed in spring 2004 to ensure public access to traditional medicinal products. "While some goods that have long been used as traditional medicines fit neatly into [the current legal] framework, the therapeutic uses of these are restricted and many are entirely excluded," AHPA President Michael McGuffin said. "The model proposed here would completely protect the current law while developing a new option that will benefit marketers who want to sell traditional medicines"...
You may also be interested in...
Traditional medicines draft paper
The comment period for a draft paper on a new model for regulating traditional medicines in the U.S. has been extended to June 30, the American Herbal Products Association announces March 29. The draft document, "A Proposed Regulatory Model for Traditional Medicines: Guiding Assumptions & Key Components," was released by the Traditional Medicines Congress in November (1"The Tan Sheet" Dec. 5, 2005, In Brief). Despite the 70 comments already received, an extension was requested by several stakeholders, AHPA says. The group also is clarifying certain "areas of confusion": the TM Congress is not suggesting that herbs marketed as supplements under DSHEA be required to be sold as traditional medicines and is not aiming to influence the practice of medicine under any therapeutic discipline...
Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings
Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.