New Drug Listing Requirement and Timetable Effective this Month

By Eric Foxman, AAHP Secretary October 1, 2017 The FDA recently introduced new requirements for the annual drug product reporting period and a new Structured Product Labeling (SPL) submission type. These requirements apply to every drug product marketed in the United States, including all homeopathic drug products, and will require action from just about everyContinue Reading

The Long-Term Vision for AAHP

By Eric Foxman, AAHP secretary October 1, 2017 During the course of the summer, AAHP president Mark Land lead the various association committees in an intense introspective series of meetings to identify strengths and challenges for our association. Meeting by telephone, email, and even in person, the result of this summer’s efforts was an 80-pageContinue Reading

Market Research Roundup

By Eric Foxman, AAHP secretary October 1, 2017 The last weeks have seen a number of market research studies published that provide background, analysis, and forecasts for homeopathic market development and growth. The fact that so many reports are now available acknowledges the potential of the homeopathic products segment. All the reports are available forContinue Reading

Belladonna: A Clinical Snapshot

By Todd Hoover, MD September 1, 2017 The original proving of belladonna was conducted by Dr. Samuel Hahnemann, who found it to become a commonly used medicine. Dr. Hahnemann described prophylactic effects of the medicine when used in treatment for scarlet fever. Interestingly, he discovered the potential prophylactic effect during an outbreak of scarlet fever,Continue Reading

How is Homeopathic Belladonna Made?

By Mark Land, AAHP president September 1, 2017 Belladonna, more commonly known as deadly nightshade, Atropa belladonna, devil’s cherries, devil’s herb, divale, dwale, dwayberry, great morel, naughty man’s cherries, and poison black cherry, is a perennial herb that has been valued for its medicinal properties for more than five centuries. Belladonna is a member of theContinue Reading

What’s New at FDA?

By Mark Land, AAHP president September 1, 2017 I took a course several years ago titled Regulatory Intelligence. The first thing the professor said was, “This course is not designed to teach you how to spy on your competitors.” Then she gave us links to 15 news feeds from the U.S. Food and Drug AdministrationContinue Reading

When Anti-Homeopathy Skeptics Strike

By Deborah Kelly and Alissa Gould, PR Managers, Boiron USA September 1, 2017 It’s typical for skeptics to fire away at anyone who posts or tweets positively about homeopathy. As manufacturers of homeopathic medicines, AAHP member companies are sometimes the target of such criticism, especially if they have an online presence. Why Not to EngageContinue Reading

The Road to OTC Monograph Reform

By Barbara A. Kochanowski, senior vice president of regulatory and scientific affairs Consumer Healthcare Products Association August 1, 2017 For the past three years, the regulated industry has been working with the U.S. Food and Drug Administration (FDA) to reform the OTC Monograph System, the regulatory framework under which most over-the-counter (OTC) products are regulated.Continue Reading

Changes are Coming to Product Labels

By Alvin J. Lorman, AAHP counsel August 1, 2017 Changes are coming to your products’ labels. Not only are there changes to the Homeopathic Pharmacopeia of the United States (HPUS) on the horizon, but our association’s Board of Directors is expected to make its soon-to-be-adopted new advertising disclaimer mandatory on labels as well. And there’sContinue Reading

FDA’s Division of Nonprescription Drug Products

By Mark Land, AAHP president August 1, 2017 The development and regulation of over-the-counter (OTC) drug products is the responsibility of the Division of Nonprescription Drug Products (DNDP) within the Center for Drug Evaluation and Research’s (CDER) Office of Drug Evaluation IV. A sponsor seeking to market its product OTC, either as a new drugContinue Reading