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)
FDA’s AI/ML Action Plan Includes ‘Tailored’ Regulatory Framework for SaMD
On January 18th 2021, the US Food and Drug Administration (FDA) released a five-part action plan for their artificial intelligence and machine learning (AI/ML) software and classified it as a medical device (SaMD).
TGA announces new fee schedule and delays in proposed regulations
For the fiscal year 2020-2021, TGA (Therapeutic Goods Administration) announces an updated fee schedule which comes in effects from July1, 2020.