Regulatory/Legislation

How Much Can Machine Learning Help Us?

June 4, 2018

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AAHP Speaking Tour

April 24, 2018

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Legislative Update: Actions Since FDA’s Draft Guidance

March 7, 2018

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United States Food and Drug Administration – Good Guidance Practices

January 30, 2018

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Steps Toward Building Grassroots Support

December 6, 2017

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

November 20, 2017

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

November 13, 2017

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What’s New at FDA?

August 31, 2017

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

August 3, 2017

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

July 25, 2017

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…

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.

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