Regulatory

AAHP 2019: Reawakening the Regulatory and Retail Dialog

By Mark Land, AAHP President This year marks the fifth year in a cycle of regulatory review of homeopathic drug product labeling, safety, and quality. AAHP has been there for the industry as an advocate and representative over the entire duration. In 2019 AAHP provided direction and regulatory thought-leadership within readm more…

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Trump Nominates New FDA Commissioner

Senate Hearing Set for Nov. 20 By Pete Evich, AAHP Govt. Relations   On Nov. 1, President Trump nominated Stephen Hahn, chief medical executive of the MD Anderson Cancer Center in Houston, to be the next U.S. Food and Drug Administration (FDA) commissioner. If confirmed by the Senate, a process readm more…

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Why It’s Crucial to Monitor FDA Guidances

By Mark Land, AAHP President It can take several years for manufacturers to implement new guidelines from the Food and Drug Administration (FDA)—and that means they could be at risk in the meantime. However, manufacturers can “get ahead of the game” by monitoring FDA’s guidance development agenda. FDA’s authority to readm more…

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Australia to Release the First Draft Report on Homeopathy Effectiveness

By Mark Land, AAHP President   Many believe the draft report arrived at a more encouraging conclusion regarding the effectiveness of homeopathy and may have been suppressed by the then conservative Australian government. After years of requests and inquiry, Australia’s National Health and Medical Research Council (NHMRC) has decided to readm more…

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2020 Democratic Presidential Run

By Pete Evich, AAHP Government Relations   As the 2020 U.S. presidential election inches closer, many Democratic hopefuls have launched campaigns to take the White House. At AAHP, we are keeping a close eye on the candidates and proposed policies that could affect the homeopathic industry. Here is an overview readm more…

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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 readm more…

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Educational 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…

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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 readm more…

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How 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…

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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 readm more…

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