Registration of Cosmetics in the USA
OVerview: Cosmetics marketed in the United States, whether manufactured domestically or imported must comply with the following regulations:•Federal Food, Drug, and Cosmetic Act (FD&C Act),
How to Register a Hand-Sanitizer with the US FDA
Overview: The US FDA considers alcohol-based hand sanitizers as Over the Counter Products (OTC). The OTC are divided into two categories either health care antiseptics
Real World Evidence for Clinical Trials in China
Overview: On January 7th, 2020, NMPA published a new guideline on “Real-World Evidence that defines Real-World Data (RWD) and Real-World Evidence (RWE) terms and clarifies
Overview of Regulatory Requirements of Software as Medical Device (SaMD)
Overview: GRP’s whitepapers provides an overview of international guidelines for Software classified as a Medical Device. What is Software as a Medical Device? International Medical
US FDA Breakthorugh Program for Medical Devices
The FDA Breakthrough Devices Program is a voluntary program that can be used by manufacturers of medical devices, and certain combination products, that provide more
US FDA’s Pre-Approval Inspections
A pre-approval inspection (PAI) is performed to contribute to FDA’s assurance that a manufacturing establishment named in a drug application is capable of manufacturing a
