Archive for January 2017
AAHP in 2016 and a Review of New Member Resources
Jan. 26, 2017 In 2016, the Education Committee produced four robust webinars, and industry leaders united at two membership meetings. As we step forward into 2017, it’s a good moment…
Read MoreThe Tale of the Contract Manufacturer: A Story Based on an AAHP Member Question
By Eric Foxman, AAHP Secretary Once upon a time, a special creature, the CIAMP (Company Interested in Alternative Medical Products), wanted Phoxman Farmaceuticals (PhoxFarm) to contract manufacture a product for…
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…
Read MoreThe European Pharmacopeia and How U.S. Manufacturers Can Use It
By Mark S. Phillips, Pharm. D. Jan. 26, 2017 On Jan. 1, 2017, the 9th edition of the European Pharmacopoeia (Ph. Eur.) became legally binding in its 37 European member…
Read MoreRegulatory 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…
Read MoreWho 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…
Read MoreA Trump Administration and a Republican-Controlled Congress
An Assessment and Outlook of the Political and Regulatory Climate for 2017 By Pete Evich, AAHP government relations January 1, 2017 The election of Donald Trump and a Republican-controlled Congress…
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