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...
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...
May 26, 2022 | Drug and Device Corner, Drugs, Medical Devices
The passing of the CARES Act in 2020, built on the authorization given to FDA in 2012 by the Food and Drug Administration Safety and Innovation Act (FDASIA), to address the problem of drug supply disruptions and shortages. The agency released a draft guidance to...
Apr 28, 2022 | FDA and USDA Regulatory Update, Tobacco
As has long been anticipated, FDA, on April 28, 2022, announced a proposed rule that would prohibit menthol as a characterizing flavor in cigarettes, and all characterizing flavors other than tobacco in cigars. Once finalized and implemented, FDA enforcement will...
