Steps Toward Building Grassroots Support
December 6, 2017 Since the FDA hearing and the FTC workshop in 2015, the homeopathic industry has received more attention than usual from regulators. While AAHP continually meets with congressional leaders in Washington and works with both agencies, your association is also working to mobilize stakeholders. It’s important for legislators to hear a cry of…
Recall Preparedness
By Mark Land, AAHP president November 20, 2017 Risks associated with the therapeutic use of healthcare products are real. Manufacturers and the U.S. Food and Drug Administration (FDA) balance these risks all of the time when making marketing authorization decisions. These risks can be evaluable or unanticipated. Evaluable risks from the direct chemical, physical, or…
Annual Certification of Drug Product Listings
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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 Administration…
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.…
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 drug…
OTC Monograph Reform
By Mark Land, AAHP president August 1, 2017 Self-medication is an important way in which American consumers treat many types of illnesses. Over-the-counter (OTC) drugs often provide effective relief in a cost-effective and accessible manner and represent the first choice of treatment for many ailments. More than 80 therapeutic categories of OTC drugs exist and…
Congress Aiming to Consider User Fee Legislation in July
By Pete Evich, AAHP government relations July 1, 2017 Bills (S 934, HR 2430) that would renew the Food and Drug Administration’s (FDA) ability to collect fees from the drug and medical device industries are expected to get their final votes in the House and Senate in July. The House may consider its bill the…
PDUFA after 25 Years
By Mark Land, AAHP president July 1, 2017 The Prescription Drug User Fee Authorization (PDUFA) first enacted in 1992 was the third major piece of drug legislation in the modern era. The first two were the Drug Amendments Act of 1962 and the Drug Price Competition and Patent Term Restoration Act of 1984. PDUFA, like…
The Homeopathic Pharmacopoeia of the United States
By Mark Land, AAHP president June 1, 2017 The Homeopathic Pharmacopoeia of the United States (HPUS) is the legal basis for marketing homeopathic drug products in the United States and many other countries around the world. The HPUS is officially recognized in the United States Federal Food Drug and Cosmetic Act and other United States…
AAHP monitors and reports on current federal regulations, legislation and government policies that affect the homeopathic community. AAHP is often the first to learn of regulatory changes that have both direct and indirect effects on our industry enabling members to stay ahead of the curve in a rapidly changing healthcare environment.