Compliance

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…

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…

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…

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…

Social Media and Products Subject to FDA Regulation

September 3, 2014

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FDA & Proprietary Names

September 3, 2014

FDA has published a draft document on “Best Practices in Developing Proprietary Names for Drugs”. This document is intended to help companies develop product names that do not cause or…

Homeopathic Quality by Design

September 3, 2014

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Status of English vs. Latin Names of Homeopathic Ingredients

January 24, 2014

The following is the text of letter from FDA to the HPCUS regarding the use of Latin names on Homeopathic drug products.

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