The various acts enforced by FDA require an adequate showing of product safety prior to introduction into the marketplace. In order to ensure adequate …
The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate comm …
Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. PMA regulates most Class III medical device. A PM …
The ICH Q10 - Pharmaceutical Quality System is a harmonized Guideline in USA, Europe and Japan and was approved in 2008. This Guideline applies to pha …
Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critic …
The ICH Q7 Guide "GMP for APIs" (formerly known as ICH Q7A) is a harmonized Guideline in USA, Europe and Japan and was approved in 2000. The guideline …
Medical Device Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements an …