Oct 17, 2022 | Cosmetics, Drugs, EASeNews, Foods, Issue of the Month, Medical Devices
Prevention of product contamination through an Environmental Monitoring Program is a requirement across FDA regulated industries. This ensures product safety and reduces the likelihood of an adverse event(s) for the consumer. An established EMP is required by FDA as part of a Good Manufacturing Practice (GMP) quality system.
Oct 6, 2022 | Foods, Issue of the Month
By Amy Scalin, M.S. Hearing from FDA often means one thing: The Agency has found issues with your operations that require a swift response and corrective actions. FDA uses numerous tools to notify firms of regulatory compliance enforcement. Most commonly, a firm will...
Aug 31, 2022 | Issue of the Month
By William A. Ruskin, EAS Independent Consultant and William L. Anderson, former partner at Crowell & Moring This article is a revision of an article that first appeared in the Lexis Nexis publication Editor’s Note: Mr. Anderson is a former partner with...
Aug 15, 2022 | Drugs, Issue of the Month
By Susan Crane, EAS Senior Advisor for OTC Drugs and Labeling As part of its mission to protect the public health, the FDA monitors the safety of drug products marketed in the United States. This is accomplished through laws enacted by Congress as well as regulations...
Jun 22, 2022 | Drugs, EASeNews, Issue of the Month, Medical Devices
By Brad Douglass, EAS Consulting Group Independent Consultant The Food and Drug Administration’s approval of Fulyzaq (crofelemer), an anti-diarrheal drug for HIV/AIDS patients, was a first for an oral, prescription botanical drug. Prior to that approval, the topical...
Jun 1, 2022 | Dietary Supplements, Issue of the Month
A bill before U.S. Congress proposes a new requirement that all dietary supplement products be electronically listed with Secretary of Health and Human Services. This move will enable the creation of a publicly available on-line registry in support of consumer...
