Compliance

FDA Office of Surveillance and Epidemiology

April 3, 2017

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 profiles of drugs available to American consumers using a variety of tools and disciplines throughout the life cycle of drugs. OSE maintains a system of…

Analytical Methods

March 28, 2017

By Mark Land, AAHP President April 1, 2017 When Samuel Hahnemann founded homeopathy at the end of the 18th century, he couldn’t possibly have fathomed the extreme capabilities of today’s analytical technologies. Most instruments currently used to assess homeopathic dilutions can resolve to below one microgram—that is to say, to less than one part per…

The State of Technology in Homeopathic Medicine

March 28, 2017

By Jim Duquesnel, VP-R&D, Hyland’s, Inc. April 1, 2017 “Be careful what you ask for!” This phrase surfaces more often than I would like in the pursuit of advancing homeopathic technology. In six-sigma training years ago, I had admired W. Edwards Deming’s emphasis on quality as the reduction in variability and control of consistency. Those…

Consumer Label Comprehension

March 3, 2017

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 argue is the most knowledgeable consumer any business has ever had. From using crowdsourcing and reviews to determine the best electronic or household appliance to…

Disclosing Relationships with Influencers on Social Media

March 3, 2017

By Deborah Kelly, public relations manager, Boiron USA March 1, 2017 The core mission of the Federal Trade Commission (FTC) is to regulate advertising so businesses won’t mislead consumers or engage in deceptive practices that would affect behavior or decisions about a particular product or service. One area of particular concern and scrutiny is endorsements.…

The FTC and the Web

February 28, 2017

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 and labeling as well as advertising has caused many to ask about the legal boundaries of the FTC’s jurisdiction. When you think of the FTC,…

The Tale of the Contract Manufacturer: A Story Based on an AAHP Member Question

January 26, 2017

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 formula, designed the labeling and…

What About Your APIs and Q7 Requirements?

January 26, 2017

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 products and closely follows a…

The European Pharmacopeia and How U.S. Manufacturers Can Use It

January 26, 2017

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 revised. The European Pharmacopoeia is…

AAHP Compliance Thru Education Webinar on FDA Inspections

December 14, 2016

The association just completed another successful Compliance Thru Education webinar: FDA Inspections of Homeopathic and Drug Manufacturing Facilities: An Agency View. This webinar, held on Dec. 1, was the last of four AAHP educational events hosted during 2016. The webinar was presented by Ms. Tamera Ely, senior policy advisor from the FDA’s Office of Compliance/Office…

Leave a Comment

You must be logged in to post a comment.