Compliance
Disclaimers in Character-Limited Media
By Mark Land, M.S., RAC-US, AAHP President The Federal Trade Commission (FTC) issued an enforcement policy statement on marketing claims for OTC homeopathic drugs on November 15, 2016.1 As a…
Read MoreContemporary Advertising
By Mark Land, MS, RAC-US, AAHP President It is not an exaggeration to say that advertising has evolved delivery, scale, and targeting exponentially with the emergence of digitally enabled content.…
Read MoreThe Importance of Purified Water Systems in the Pharmaceutical Industry
By Mark Land, MS, RAC-US, AAHP President My first experience with a water treatment system was a double deionization, pre- and post-filtration technique. There was no storage or recirculation. It…
Read MoreCompliance Efforts — Where to Put One’s Priorities?
by Eric Foxman, Pharm. (Ret.) FDA Compliance Being in compliance and being prepared for an inspection are time and resource- consuming activities. Yet both are necessary and required of every…
Read MorePresent Foresight to Protect the Future
By Mark Land, MS, RAC-US, AAHP President AAHP planned this issue of the newsletter to focus on stewardship several months ago as part of our annual editorial calendar. I knew…
Read MoreQuality/Regulatory Support of New Product Introductions
By Mark Land, MS, RAC-US, AAHP President The introduction of a new product at retail is a team effort. Meeting technical information requirements to support a new product introduction is…
Read MoreFDA Issues FY23 Drug Safety Priorities Report
In February 2024, FDA’s Center for Drug Evaluation and Research (CDER) published its ninth yearly report describing key safety programs and activities, and illustrating the depth and versatility of drug…
Read MoreThe Homeopathic Pharmacopoeia of the United States
By Mark Land, MS, RAC-US, AAHP President The Homeopathic Pharmacopoeia of the United States (HPUS) is the legal basis for marketing homeopathic drug products in the United States and many…
Read MoreFDA Guidance Document Development Process
By Alvin J. Lorman, AAHP Counsel The Food and Drug Administration (FDA) is seeking public comment on a draft “Report and Plan on Best Practices for Guidance.” Guidance documents, rather…
Read MoreIncreased FDA Scrutiny of Eye Care Category
By Alvin J. Lorman, AAHP Counsel The Food and Drug Administration (FDA) last week continued its heightened surveillance on ophthalmic drug products sold without FDA approval or without complying with…
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