Compliance
Speakers at FDA Hearing Praise Success of Homeopathic Regulatory Framework
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…
Read MoreAAHP Addresses OTC Homeopathic Drug Products for Asthma
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…
Read MoreFDA’s Quality Metrics Initiative – From Compliance to Performance
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…
Read MoreStability Testing
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…
Read MoreDeployment of FDA Inspection Resources
By Mark Land, VP Operations and Regulatory Affairs at Boiron A primary mission of the Food and Drug Administration is to conduct comprehensive regulatory coverage of all aspects of production…
Read MoreFDA Establishes Unique Facility Identifier
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…
Read MoreAssays of homeopathic preparations
An interesting contribution, Quality Aspects Of Homoeopathic Preparations, appeared in Pharmeuropa Online, a publication of the European Directorate for the Quality of Medicines and HealthCare (EDQM). In his paper, Professor…
Read MoreTwo 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…
Read MoreSocial Media and Products Subject to FDA Regulation
by Eric L. Foxman The use of the internet and social media promotion has complicated the previously simple review of FDA regulated industries by the Agency. In response, FDA has…
Read MoreFDA & 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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