Regulatory/Legislation

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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2014 Elections and Effect on Homeopathic Industry

November 20, 2014

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Social Media and Products Subject to FDA Regulation

September 3, 2014

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AAHP Submits Comments to US Congress on Safety Standards for Homeopathic Drug Products

February 1, 2014

The following is the text if a letter submitted to Senators Harkin and Enzi of the Senate Health Education, labor and Pensions Committee.

Senator Harkin Writes to FDA regarding Homeopathic Drug Products

January 31, 2014

Click to download a PDF.

FDA responds to Senator Harkin regarding Homeopathic Drug Products

January 30, 2014

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Overview of Homeopathic Drug Product Regulation

January 29, 2014

The Homeopathic Pharmacopoeia Convention of the United States (HPCUS) is responsible for the publication of the Homoeopathic Pharmacopoeia of the United States* (HPUS*). Through its ongoing work, the HPCUS offers assurances that homeopathic medications are safe, accessible and legal in the United States.

The AAHP Lobbies Congress on the Drug Quality And Safety Act

January 28, 2014

The issue of pharmaceutical compounding came to the fore in 2012 when it was reported that more than 50 deaths and widespread serious medical problems were the result of fungal meningitis linked to contaminated products from the New England Compounding Center (NECC).

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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