Archive for May 2019
A First Look at AAHP Summit Speakers
We are thrilled to offer a first look at the speakers and sessions for our upcoming Summit on Challenges and Solutions in Quality & Safety of Homeopathic Drug Products! This…
Read MoreHow to Work with FDA on Voluntary Recalls
By Mary Borneman, Sr. Director, Communications & Public Affairs, Standard Homeopathic Company/Hyland’s, Inc. In April 2019, U.S. Food & Drug Administration (FDA) published a draft guidance* Initiation of Voluntary…
Read MoreSafe Drugs, Happy Consumers: Sterility Assurance Programs
By Kristina Skowronek, Director of Quality and Regulatory Compliance, Boiron USA USP GENERAL CHAPTERS, GENERAL INFORMATION, 〈1211〉 STERILIZATION AND STERILITY ASSURANCE OF COMPENDIAL ARTICLES If we were to manufacture a…
Read MoreInitiation of Voluntary Recalls: Draft Guidance for Industry and FDA Staff
By Mark Land, AAHP President Product recalls are an important tool that manufacturers and the U.S. Food and Drug Administration (FDA) use to minimize exposure to potentially harmful or…
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