Compliance
Quality/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…
Read MoreFTC Proposes Rule Against False or Misleading Consumer Reviews and Testimonials
By Alvin J. Lorman, AAHP Counsel The Federal Trade Commission (FTC) has announced that it is moving forward with a proposed Trade Regulation Rule that is intended to prevent fake,…
Read MoreFDA Cracks Down on Testing for Glycerin Contaminants — Again
By Al Lorman, AAHP Counsel The Food and Drug Administration (FDA) has begun another campaign to protect consumers from products that contain glycerin potentially contaminated with diethylene glycol (DEG) or…
Read MoreFDA’s Center for Drug Evaluation and Research’s (CDER) Office of Compliance
By Mark Land, M.S., RAC, AAHP President The Office of Compliance (OC) shields patients from poor quality, unsafe, and ineffective drugs through compliance strategies and risk-based enforcement actions. OC makes…
Read MoreFDA Office of Compliance Annual Report FY 2022
FDA’s Office of Compliance (OC) recently published its Annual Report for Fiscal Year 2022.1 The report was introduced by Director Jill Furman. Ms. Furman took over the director’s role in…
Read MoreThe HPCUS Friends of the Pharmacopoeia Program
By Dr. William Shevin, President, HPCUS Due to challenges in general for homeopathy and specifically for the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), the standards-setting organization is launching…
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