Regulatory
Congress Aiming to Consider User Fee Legislation in July
By Pete Evich, AAHP government relations July 1, 2017 Bills (S 934, HR 2430) that would renew the Food and Drug Administration’s (FDA) ability to collect fees from the drug…
Read MorePDUFA after 25 Years
By Mark Land, AAHP president July 1, 2017 The Prescription Drug User Fee Authorization (PDUFA) first enacted in 1992 was the third major piece of drug legislation in the modern…
Read MoreThe 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…
Read MoreDisclaimers 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…
Read MoreUnited 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…
Read MoreFDA 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…
Read MoreConsumer 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…
Read MoreThe 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…
Read MoreCongress 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…
Read MoreWhat 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…
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