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...
Jan 1, 2021 | Drugs, EAS in the News Drugs, EAS in the News Medical Device, Extra Article, Medical Devices
EAS published an article in MedTech Intelligence on the importance of component GMP requirements for drug-device combination products. “The rapid development of combination products—biologics, pharmaceuticals and their devices—provides great opportunity for...
Jan 6, 2020 | EAS in the News Medical Device, Medical Devices
MedTech Intelligence January 6, 2020 Developing a Mobile Medical Device? FDA Is Watching Amy...
Oct 7, 2019 | EAS in the News Medical Device, Medical Devices
ISPE iSpeak blog October 7, 2019 https://ispe.org/pharmaceutical-engineering/ispeak/use-safety-and-performance-determine-substantial-equivalence-fda Amy Scanlin
Apr 11, 2019 | EAS in the News Medical Device, Medical Devices
MedTech Intelligence April 11, 2019 510(k) Guidance Shifts Away Substantial Equivalence in Favor of Performance Testing and Criteria Jay...
Dec 7, 2018 | EAS in the News Medical Device, Medical Devices
MedTech Intelligence FDA Encourages Innovation and Safety as Part of Medical Device Regulatory Overhaul Amy Scanlin December 7,...