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 correction or removal from the…
Meet 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 his career by completing two…
New FDA Documents on Cough/Cold Products and Annual Reporting
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GOP 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, the party’s lawmakers in Congress…
FDA’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 inspections of homeopathic manufacturers in…
An In-Depth Review of AAHP’s 2021 Summit
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 to the presenters and the behind-the-scenes organizers of the event. As an…
Success: Implementing HPUS Guidelines for FDA Compliance, Part 2
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 (HPCUS) and presented by AAHP. This program aims to develop…
International Coalition of Homeopathic Associations
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 speaks of “regulatory creep,” a phenomenon whereby regulatory authorities accelerate…
Homeopathic 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 virtually. During this time, more…
The Environment for Homeopathy in Canada
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 model of support such as traditional medicines and homeopathic products. There are organizations that…
AAHP monitors and reports on current federal regulations, legislation and government policies that affect the homeopathic community. AAHP is often the first to learn of regulatory changes that have both direct and indirect effects on our industry enabling members to stay ahead of the curve in a rapidly changing healthcare environment.
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