Compliance

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…

Label Comprehension Studies for Nonprescription Drug Products

December 14, 2016

The Food and Drug Administration (FDA) sometimes requires sponsors to conduct label comprehension studies that are designed to evaluate proposed nonprescription drug product labeling. A label comprehension study assesses the extent to which consumers understand the information on nonprescription drug product labeling and then apply this information when making drug product use decisions in a…

The Importance of Standard Operating Procedures

November 9, 2016

By Mark Land, AAHP President Manufacturers of health care products rely on precision, rigor and consistency to produce reliable products for patients, physicians and consumers time and again. To drive the kind of culture that consistently and effectively produces results of this nature, companies must first create a culture where quality objectives are transparent, well…

Document Management Systems

September 2, 2016

It is often said that the pharmaceutical industry produces two products: healthcare products and the paper that goes along with it. During the past 20 years, we have seen a transition from paper-based format to the production of electronic-based information that provides a rich foundation of presentation options. The pharmaceutical industry was reluctant to adopt…

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