Regulatory

AAHP Speaking Tour

By Mark Land, AAHP President April 24, 2018 Since the beginning of the year I have embarked on a tour to inform the community of AAHP’s position on the FDA’s draft guidance, Drug Products Labeled as Homeopathic, and understand the issues on the minds of our community members. During this readm more…

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Legislative Update: Actions Since FDA’s Draft Guidance

By Pete Evich, AAHP government relations March 1, 2018 Given AAHP’s concerns with the omissions of key homeopathic references and definitions in the United States Food and Drug Administration’s (FDA) December 2017 draft homeopathic guidance, AAHP has instituted a Capitol Hill strategy to draw attention to the document’s deficiencies. The readm more…

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United States Food and Drug Administration – Good Guidance Practices

By Mark Land, AAHP president February 1, 2018 The Food and Drug Administration (FDA) amended its administrative regulations to codify its policies and procedures for the development, issuance, and use of guidance documents in September 2000.1 This action was necessary to comply with requirements of the Food and Drug Administration readm more…

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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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