Understanding the expectations and challenges The pharmaceutical and medical device industries are seeing a substantial increase in combination products, and the related regulatory environment has been very dynamic. Recently, I was privileged to moderate a PharmaVOICE webinar on the latest U.S. FDA post-marketing safety reporting (PMSR) ruling and guidance. Expert …
Are you ready? Impact of upcoming regulatory requirements on combination product reporting
产品组合:they? Any product formed from the combination of a drug, a device and a biologic is referred to as a combination product. Under 21 CFR 3.2 (e) this includes two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as …