USFDA Publishes updated definitions FOR ‘Face-to-Face Meeting’
The FDA publishes updated Definitions of Face‑to‑Face Formal Meetings.
FDA-Advancing Real World Evidence Program
On October 2022, the U.S. Food and Drug Administration is announcing the Advancing Real-World Evidence (RWE) Program
The USA FDA updated Electric CPP’s with quick response QR code
Beginning on March 25, 2022, the FDA will be adding a unique quick response (QR) code to electronic Certificates of Pharmaceutical Products (eCPPs)
Japan’s PMDA Remote Inspections
The PMDA clarifies its requirements for conducting remote compliance inspections related to drugs and regenerative medical products.
China’s NMPA Publishes the “Cosmetic Supervision and Administration Regulation”
On June 29,2020 The National Medical Products Administration (NMPA) published a new cosmetic regulation known as the “Cosmetic Supervision and Administration Regulation”.
QMS Implementation for Class I Devices Under EU MDR
OVERVIEW The European parliament had signed off second round of corrigenda in December 2019 considering mounting pressure from device manufacturers, notified bodies and industry associations. The notified bodies have been receiving large number of applications for CE marking in order to comply with May 2020 deadline issued for MDR. However, the corrigenda may postpone […]