Compliance
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 readm more…
Read MoreA Guide to Homeopathic Substantiation: Making Label Claims Compliant with FDA & FTC
By Eric Foxman, R.Ph, AAHP Secretary What is substantiation? An online search of 20 dictionaries provides four definitions, three of which are closely related and particularly apply to our topic: the act of showing something to be true, or of supporting a claim with facts;[1] to establish by proof or competent evidence;[2] and to readm more…
Read MoreA New Emphasis on Safety Levels & Other Highlights from the HPCUS 2019 Annual Meeting
By Eric Foxman, Senior Scientist, HCPUS and Secretary, AAHP The Homeopathic Pharmacopeia Convention of the United States (HCPUS) held its annual meeting in April 2019. The HCPUS—the group of homeopathic professionals responsible for publishing the Homeopathic Pharmacopoeia of the United States, our industry’s recognized compendium—came together to identify key readm more…
Read MoreSummit 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 readm more…
Read MoreEducational Webinar Resources Available
Missed an education opportunity? Need materials for your mandated employee training? You have a second chance! AAHP webinars can help fulfill your required mandatory staff training requirements. Homeopathic manufacturers and marketers have found AAHP to be an excellent third-party source for this training. All DVD’s include an MP4 recording readm more…
Read MoreA 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 readm more…
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 Recalls Under 21 CFR Part 7, Subpart C (“the Draft Guidance”). The purpose of this new guidance is “to clarify readm more…
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 drug product that is purported to be sterile but cannot be terminally sterilized without ingredient or package degradation, a sterility readm more…
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 ineffective products.1 Drug product recalls are voluntary — that is to say, FDA does not have legal authority to recall readm more…
Read MoreOverview: 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 readm more…
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