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...
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 The agency released a draft guidance to...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 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...
Apr 19, 2022 | Drug and Device Corner, Drugs, Medical Devices
We are 5 months out from the UDI / GUDID enforcement date of 22 September 2022 for Class I and unclassified devices, are your processes in place? Do you know what requirements are applicable to your operation? Helpful information can be found on FDA’s webpage GUDID...
Apr 19, 2022 | Medical Devices, On Demand Webinar
U.S. FDA’s Latest Requirements for the 510(k) Presented by John Lincoln, EAS Independent Consultant. The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process, others are exempt, and some must go through the...
