Compliance

FDA Guidance Document Development Process 

January 23, 2024

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…

Increased FDA Scrutiny of Eye Care Category 

September 18, 2023

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…

FTC Proposes Rule Against False or Misleading Consumer Reviews and Testimonials

August 22, 2023

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,…

FDA Cracks Down on Testing for Glycerin Contaminants — Again

June 13, 2023

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…

FDA’s Center for Drug Evaluation and Research’s (CDER) Office of Compliance

June 13, 2023

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…

FDA Office of Compliance Annual Report FY 2022

June 7, 2023

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…

The HPCUS Friends of the Pharmacopoeia Program

May 16, 2023

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…

Summary of FDA’s “Report on the State of Pharmaceutical Quality: Fiscal year 2021”

February 7, 2023

By Mark Land, M.S., RAC, AAHP President Introduction In August of 2022, the United States Food and Drug Administration (FDA) published its fourth annual Report on the State of Phar­maceutical…

What’s new at FDA?

February 7, 2023

The United States Food and Drug Administration is a large organization that changes daily. From the perspective of homeopathic companies, a few important things stand out. FDA published the final…

FTC Updates Health Claims Substantiation Guidance

January 12, 2023

By Alvin J. Lorman, AAHP Legal Counsel The Federal Trade Commission last month released a lengthy guidance document on the substantiation it expects for health claims, Health Products Compliance Guidance.…

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