Assays of homeopathic preparations
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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 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…
Social Media and Products Subject to FDA Regulation
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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 contribute to medication errorsor otherwise contribute to the misbranding of the drug. With safety in mind, it describes design practices to help avoid such errors…
Homeopathic Quality by Design
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Unseen Plant Contaminants In Raw Materials
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Status of English vs. Latin Names of Homeopathic Ingredients
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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