Toxicology & How to Calculate the First Safe Dilution
Matthew D. Reed, PhD, DABT, ATS led two workshops at AAHP’s recent Safety Summit, providing an in-depth introduction to the principles of toxicology and risk assessment, an appraisal of the role of toxicological studies in pharmaceutical development, and a review of the methodology for assigning first safe dilution levels. In assessing risk, Dr. Reed said…
A Guide to Homeopathic Substantiation: Making Label Claims Compliant with FDA & FTC
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A New Emphasis on Safety Levels & Other Highlights from the HPCUS 2019 Annual Meeting
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Summit Photos: Experience the Excitement
The AAHP community is still abuzz from all the excitement, networking, and learning that took place at last month’s Quality and Safety Summit in Baltimore! Between the opening reception and following day of sessions, we hosted more than 100 people from five countries across the globe. With a keynote session from Francis Godwin of the…
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 unique one-day workshop is designed to help you manufacture safe products while complying within FDA and FTC guidelines. Some of the workshops included in the…
How to Work with FDA on Voluntary Recalls
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Safe 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 drug product that is purported to be sterile but cannot be terminally sterilized without ingredient or package degradation, a sterility assurance program would be absolutely…
Initiation of Voluntary Recalls: Draft Guidance for Industry and FDA Staff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 ineffective products.1 Drug product recalls are voluntary — that is to say, FDA does not have legal authority to recall a drug product. They do,…
Overview: Membership Meeting 2019
The membership of AAHP came together on March 8 for the association’s semiannual Membership Meeting. Taking place during Natural Products Expo West in Anaheim, Calif., AAHP members convened to hear updates on projects and initiatives, network, and elect new leadership before hitting the tradeshow floor. Three-Pronged Strategic Approach for 2019 AAHP president Mark Land kicked…
Reduce Risk with Product Substantiation
When bringing products to market, it is essential to build a platform that allows all information generated to be available for future use,” advised Susan J. Hewlings, PhD, RD, during a preview for her workshop this June at the AAHP Summit in Baltimore. Guest speaker at AAHP’s March 8 Membership Meeting during Natural Products…