Compliance

Homeopathic Industry Proposes More Broad Use of Disclosures to FTC as the Path Forward

September 22, 2015

Industry leaders provide perspective on partnership opportunities for Federal Trade Commission Washington, D.C., Sept. 21, 2015— To better help consumers make informed choices, the American Association of Homeopathic Pharmacists (AAHP) proposed strengthening product label and advertising disclosures to the Federal Trade Commission (FTC) today in Washington, D.C. at the agency’s “Homeopathic Medicine & Advertising” workshop.…

The Homeopathic Industry Needs YOUR Support

August 3, 2015

Over the past few decades, the homeopathic industry has grown into a multibillion-dollar industry and national drug stores are finally recognizing the merits of our product. But as the industry has grown, so, too, has skepticism from legislators and regulators. While we successfully argued for the effectiveness of current regulations at a FDA hearing a few months…

Speakers at FDA Hearing Praise Success of Homeopathic Regulatory Framework

May 14, 2015

Silver Spring, Md., April 20, 2015—The American Association of Homeopathic Pharmacists (AAHP) today told the U.S. Food and Drug Administration that the agency’s regulatory policy for homeopathic medicines has worked effectively for the last 25 years to protect the public health and provide consumer access to safe homeopathic medicines. AAHP, the industry’s trade association, was…

AAHP Addresses OTC Homeopathic Drug Products for Asthma

March 30, 2015

The American Association of Homeopathic Pharmacists (AAHP), representing the principal manufacturers and distributors of homeopathic medicines in the United States, said today it fully supports the Food and Drug Administration’s position that consumers should seek the advice of their health care provider if they suspect they or their children are experiencing symptoms of asthma, which…

FDA’s Quality Metrics Initiative – From Compliance to Performance

February 17, 2015

By Mark Land, VP Operations and Regulatory Affairs at Boiron The 2012 Food Drug Administration Safety and Innovation Act (FDASIA) gave FDA new tools to encourage high quality manufacturing of pharmaceuticals and enhanced the agency’s ability to respond to, prevent and mitigate the risk of drug shortages. Section 705 of the Act specifically requires FDA…

Stability Testing

February 17, 2015

The AAHP office just received a copy of an article, Stability Testing of Medicinal Products According to Homeopathic Principles; this appeared in Pharmaceutical Industry (71, Nr. 12). The article was co-written by 8 colleagues of European companies, of which 5 are members, or related to members, of the AAHP. The article addresses the implementation, in…

Deployment of FDA Inspection Resources

January 23, 2015

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FDA Establishes Unique Facility Identifier

December 19, 2014

In November, the Food and Drug Administration published a Guidance for Industry entitled: Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration. This guidance is a direct result of the Food and Drug Administration Safety and Innovation Act of July 2012.  Sections 701 and 702 of FDASIA require FDA to specify the…

Assays of homeopathic preparations

December 19, 2014

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Two Informative FDA Guidance documents

October 13, 2014

FDA has issued a Guidance for Industry document, ANDA Submissions ― Refuse-to-Receive Standards, which contains helpful hints on the Agency’s thinking and practices. Much of the contents may not be applicable to members of our industry, because homeopathic drug products are, by and large, not subject to the ANDA process, but hidden within the Guidance…

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