4 Types of FDA Inspections & How to Prepare
Risk. It’s a hot word in the homeopathic industry right now. Even before the FDA issued its draft guidance, the agency used a risk-based approach to site inspections. With the 2012 Safety and Innovation Act, the agency nixed a set inspection calendar and began visiting manufacturers “in accordance with a risk-based schedule” that considers “known…
Little-Known Facts About 3 Unique Starting Materials
By Mary Beth Watkins and Eric Foxman The array of substances used for homeopathic drug products is wide and varied. Many homeopathic starting materials also have uses outside of our industry and might be familiar by their common English names. We’ve reformatted “Drug Facts” panels to give you several little-known facts about Formica rufa,…
Clearing the Air: Consider Slack-Fill
By Mark Land, AAHP President Although the term might not be familiar, you may have been fooled by “slack-fill” as a consumer of many types of products at one time in your past. It’s the difference between the actual capacity of a container and the volume of the product inside. To prevent consumers being…
Your Products Might Require Child-Resistant Packaging Statements
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Alert: FDA Drug Listing Records Subject to Inactivation
By Eric Foxman, AAHP Secretary Beginning September 14, 2019, and every January, FDA will begin to inactivate drug listings that are uncertified in the previous renewal period. Last month, the Food and Drug Administration (FDA) announced that it intends to inactivate drug listing records that are a) not certified as being active and up…
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…