Regulatory
FDA 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 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 More118th Congress: Legislative Productivity Stymied by Partisan Divide
The 2022 midterm election resulted in putting Republicans in control of the House of Representatives by the narrowest of margins (222 to 213). With the Democrats succeeding in maintaining control…
Read MoreThe History and Future of Regulations for Homeopathy
The principal federal regulators of the manufacture, sale, and marketing of homeopathic drug products are the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). Both agencies recognize…
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 MoreA High-Level Comparison of Homeopathic Product Regulation in the US, EU, and Canada
Two members of the AAHP Board, Mark Land and Eric Foxman, attended a June meeting with members of similar organizations from the European Union (EU), the United Kingdom (UK), and…
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 More