Regulatory
House and Senate Advance FDA User Fee Reauthorization Bills
By Pete Evich In the month of June, both the House and Senate advanced separate pieces of legislation that reauthorize FDA’s prescription drug, medical device, biosimilars, and generic drug user…
Read MoreThe Status of Homeopathic Medicinal Products in the European Union
By European Coalition on Homeopathic & Anthroposophic Medicinal Products (ECHAMP) Homeopathic medicinal products have a strong foundation in the EU law. Specific EU legislation for homeopathic medicinal products has…
Read MoreFDA Seeks Accelerated Drug Approval, DSHEA, Cosmetics Legislative Reforms
By Pete Evich, AAHP Government Relations As part of the President’s FY 2023 Budget proposal, FDA has called upon Congress to take up legislation that would give the agency additional…
Read MoreThe Regulation of Homeopathic Medicines in 2022
By Mark Land, AAHP President The content in our June 2022 newsletter on regulation turned out quite different than I imagined when we discussed it at an editorial planning…
Read MoreRegulation of Homeopathic Medicines in Canada
Submitted by David Skinner, Canadian Homeopathic Pharmaceutical Association Homeopathic medicines (HMs) are regulated in Canada by Health Canada, the federal government department responsible for ensuring the safety, efficacy, and…
Read MoreRegulatory Status of Homeopathy in the EU & UK: What’s Happened Since Brexit?
By Steve Mann, Director of External Regulatory Affairs, Nelsons To say the world has changed over the last couple of years might just be the understatement of the century…
Read MoreA Global Perspective on Effectiveness Standards for Homeopathic Medicinal Products: Is there a “Third Way”?
By Robbert van Haselen, Chair, HPCUS Clinical Documentation Committee; Director, World Integrated Medicine Forum We currently live in an increasingly polarized world, and this is also reflected in the…
Read MoreBe ’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…
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…
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…
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