Regulatory
What’s New at FDA?
By Mark Land, AAHP president September 1, 2017 I took a course several years ago titled Regulatory Intelligence. The first thing the professor said was, “This course is not designed…
Read MoreThe Road to OTC Monograph Reform
By Barbara A. Kochanowski, senior vice president of regulatory and scientific affairs Consumer Healthcare Products Association August 1, 2017 For the past three years, the regulated industry has been working…
Read MoreFDA’s Division of Nonprescription Drug Products
By Mark Land, AAHP president August 1, 2017 The development and regulation of over-the-counter (OTC) drug products is the responsibility of the Division of Nonprescription Drug Products (DNDP) within the…
Read MoreOTC Monograph Reform
By Mark Land, AAHP president August 1, 2017 Self-medication is an important way in which American consumers treat many types of illnesses. Over-the-counter (OTC) drugs often provide effective relief in…
Read MoreCongress 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…
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