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...
Apr 22, 2022 | Issue of the Month, Medical Devices
By Susan Crane, EAS Independent Consultant It’s now been 5 years since FDA updated the regulations for establishment registrations and drug listings. Despite numerous on-line reference materials and tutorials available, it appears that some companies still have...
Mar 30, 2022 | Foods, Issue of the Month
By Jayne Roth, M.P.H, REHS, EAS Independent Consultant At the end of 2021, a survey fielded by the National Restaurant Association, showed that 78% of operators said their restaurant did not have enough employees to support customer demand. Understaffing is not only...
Feb 28, 2022 | Foods, Issue of the Month
By Shawna Lemke, EAS Independent Consultant The noble pursuit of ensuring food safety is as old as time. Historians find evidence as far back as ancient Egypt and Rome of dietary laws, labeling and inspections put in place at least in part to address food safety. In...
