Two Informative FDA Guidance documents

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…

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Sept ’14 Member Meeting Successes

The AAHP’s Semi-Annual Member Meeting in Baltimore was an unparalleled success with two new highlights capping the event. After an opening welcome by AAHP President Mark Land, the meeting began…

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AAHP Semi-Annual Meeting

The AAHP’s Semi-Annual Meeting will be held Friday, September 19 in Baltimore, MD at 9am. We will meet in the Holiday Inn, Inner Harbor at 301 West Lombard Street, just…

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FDA & Proprietary Names

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…

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Homeopathic Quality by Design

by Mary Beth Watkins   Quality by Design, the systematic approach to pharmaceutical development and manufacturing, is a now ubiquitous in the pharmaceutical industry and allied industries. You cannot read…

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Overview of Homeopathic Drug Product Regulation

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.

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