The Homeopathic Pharmacopoeia of the United States
By Mark Land, AAHP president June 1, 2017 The Homeopathic Pharmacopoeia of the United States (HPUS) is the legal basis for marketing homeopathic drug products in the United States and…
Disclaimers in Advertising and Labeling: What Do They Do? Who Does What?
By Mark Land, AAHP President The FTC has long recognized that marketing claims may include additional explanatory information to prevent the claims from being misleading. This is FTC’s way of…
United States Food and Drug Administration Office of Pharmaceutical Quality
By Mark Land, AAHP President May 1, 2017 The Office of Pharmaceutical Quality (OPQ), created in Jan. 2015, enhances the U.S. Food and Drug Administration Center for Drug Evaluation and…
FDA Office of Surveillance and Epidemiology
By Mark Land, AAHP President April 1, 2017 FDA’s Office of Surveillance and Epidemiology (OSE) is positioned within the Center for Drug Evaluation and Research (CDER). OSE evaluates the safety…
Consumer Label Comprehension
By Mary Borneman, Sr. Director of Communications & Public Affairs, Hyland’s, Inc. March 1, 2017 It’s not news that the Internet and access to information has created what one could…
The FTC and the Web
By Alvin J. Lorman, Association Counsel March 1, 2017 The recent claim by the Federal Trade Commission (FTC) that its policy statement on marketing of homeopathic drugs applies to labels…
Congress to Tackle “Must Pass” FDA Legislation Next Year
The Prescription Drug User Fee Act (PDUFA) authorizes the Food and DrugAdministration (FDA) to collect fees from Rx pharmaceutical companies to help fund the agency’s drug review work, hire FDA…
What About Your APIs and Q7 Requirements?
By Eric L. Foxman, R.Ph. Jan. 26, 2017 In September 2016, the U.S. Food and Drug Administration (FDA) issued a guidance document, entitled Q7 Good Manufacturing Practice Guidance for Active…
Regulatory Policy Analysis
A Tool for Evaluating the Regulatory Framework for Homeopathic Drug Products By Mark Land, AAHP President Today the combination of drug regulations, approval options, cost controls and societal health care…
Who Regulates Your Product Labels?
Does the U.S. Food and Drug Administration (FDA) regulate homeopathic product labels? Or does the U.S. Federal Trade Commission (FTC)? Is it both? While most members of the homeopathic industry…
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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