Jul 6, 2022 | Drug and Device Corner, Drugs, Medical Devices
The FDA is tightening up the validation process in their NDC drug listing system CDER Direct. Prior to 2022, Relabelers and Repackers were able to list their products NDC/label without identifying the source NDC. As of 2022, the drug listing of a repackaged or...
Jul 3, 2022 | Cosmetics, Dietary Supplements, Drugs, EAS in Action, EAS in the News Cosmetics, EAS in the News Dietary Supplements, EAS in the News Drugs, EAS in the News Medical Device, EASeNews, Medical Devices
EAS Consultant, Tamika Cathey, is featured in Tablets and Capsules magazine with an article on establishing an effective environmental monitoring program. Contamination is costly, with recalls and fines for problematic products in the hundreds of millions. EAS offers...
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 3, 2022 | Client Update, Tobacco
FDA’s Center for Tobacco Products (CTP) has announced the selection of a new CTP director, Brian A. King, Ph.D., M.P.H. Dr. King previously worked at the Centers for Disease Control and Prevention’s Office on Smoking and Health. Dr. King is charged with furthering...
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...
Jun 1, 2022 | Foods, Under the Microscope, Veterinary
The American Pet Products Association (APPA) estimates that 68% percent of U.S. households own a pet, according to the 2017-2018 National Pet Owners Survey. That means roughly 85 million families in the U.S. have a pet in their household. Many households treat their...