Regulatory

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 readm more…

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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 readm more…

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Annual Certification of Drug Product Listings

By Leonard Krause, FDA Connect November 1, 2017 It is that time of year again. Days are getting shorter and colder, and AAHP members who manufacture homeopathic and over-the-counter (OTC) products need to renew their drug manufacturing establishments with U.S. Food and Drug Administration (FDA). This year, however, add one readm more…

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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 readm more…

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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 readm more…

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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, readm more…

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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 readm more…

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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 readm more…

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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 readm more…

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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 readm more…

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