Regulatory
Be ’Recall Ready’: FDA Wants to Help You Fulfill Your Regulatory Requirements
By Eric Foxman, AAHP Secretary Does your company market or distribute an FDA-regulated product? If so, then FDA has a document for you. FDA wants all manufacturers and downstream distribution faculties to be prepared with a recall plan so they can quickly and effectively react if a violative product needs readm more…
Read MoreMeet the Incumbent FDA Commissioner, Robert Califf, MD
Prominent cardiologist Robert Califf, MD, will once again serve as FDA Commissioner after being confirmed by the Senate on Feb. 15. Dr. Califf was first nominated to the position by President Joe Biden in November 2021. After graduating from Duke University School of Medicine, this native of southern Carolina began readm more…
Read MoreNew FDA Documents on Cough/Cold Products and Annual Reporting
The Food and Drug Administration recently released two documents of interest to manufacturers and distributors of homeopathic drugs. The first is a “consumer update” concerning the use of cough/cold products in young children. It specifically calls attention to the fact that homeopathic products have never been reviewed by the agency readm more…
Read MoreGOP Buoyed by Election Outcome; Democrats View Economic Plan as Difference Maker in 2022
By Pete Evich, AAHP Lobbyist and Vice President at Van Scoyoc Associates Republicans touted their electoral gains across the country on Tuesday, Nov. 2, believing that voters may be rejecting the policies that Democrats are pursuing in Washington. However, as Democrats came to terms with the statewide voting results, readm more…
Read MoreFDA’s Growing Expertise in Homeopathic Manufacturing
By George Bernstein, PhD If you have participated in AAHP Summits over the past couple of years, you are no doubt aware that FDA has raised the bar regarding compliance by homeopathic manufacturers with 21 CFR Part 211 (GMPs). I have been present in the audit room during FDA readm more…
Read MoreAn In-Depth Review of AAHP’s 2021 Summit
By Eric L. Foxman, Pharmacist, AAHP Secretary Having listened to the speakers at AAHP’s 2021 Summit: Implementing HPUS Guidelines for FDA Compliance, Part 2, I came away with several thoughts that will be important to manufacturers and marketers in the coming months and years. But first a huge thank you readm more…
Read MoreSuccess: Implementing HPUS Guidelines for FDA Compliance, Part 2
By Mark Land, AAHP President Co-hosted by AAHP and HPCUS on June 15, the Summit: Implementing HPUS Guidelines for FDA Compliance, Part 2 was an overwhelming success from multiple perspectives. This was the second installment of a compliance program being developed by the Homeopathic Pharmacopoeia Convention of the United States readm more…
Read MoreInternational Coalition of Homeopathic Associations
By Mark Land, AAHP President David Skinner of the Canadian Homeopathic Pharmaceutical Association recently wrote that there is a need for an international coalition of homeopathic associations. He makes this recommendation based the perceived need to monitor and respond to the international implications of actions taken by individual regulators. David readm more…
Read MoreHomeopathic Pharmacopoeia Convention Activities 2020–2021
In early May, Eric Foxman, AAHP Secretary and Senior Scientist with HCPUS, presented a webinar on updates and activities of the Homeopathic Pharmacopoeia Convention of the United States. He noted that over the past 12 months, the HPCUS held almost 40 meetings; the pandemic circumstances forced all to be held readm more…
Read MoreThe Environment for Homeopathy in Canada
By David Skinner, Association Manager, Canadian Homeopathic Pharmaceutical Association In the global context, Canada is a very small market, but the dynamics are no different than in other large markets like the United States. Above the 49th parallel, there are professional critics of all things falling outside the modern science readm more…
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