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 to reflect on other highlights that brought value to the membership. Legal & Regulatory AAHP recently met with the Federal readm more…

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The 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 it. Over cheesecake and ice cream, they discussed the project and agreed to do business together. The CIAMP created the readm more…

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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 staff, and improve systems. The end goal of this user fee collection system is more timely approval of human drug readm more…

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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 Pharmaceutical Ingredients—Guidance for Industry. The document applies to the manufacture of Active Pharmaceutical Ingredients (APIs) for use in human drug readm more…

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The 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 countries and the European Union. Compared to the 8th edition, more than 50 percent of the text is new or readm more…

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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 goals yield outcomes that are no longer obvious or predictable. So complex is the process that the field of regulatory readm more…

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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 have long understood that the FDA is responsible for over-the-counter (OTC) drug labels and labeling and the FTC is responsible readm more…

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A 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 will mark a change from the “divided government” norm that has reigned over Washington during the last six years. While readm more…

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