Category: Standards

EU MDR Regulations

November 22, 2022
Standards

Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC, which concerns medical devices,...

EMA, EU MDR, EU MDR Regulations, EUDAMED, MDR

USA/Canada/UK/EU approved product Labels: Aug 2022

September 27, 2022
Standards

Below are some analytics and counts of Product labels released from Canada, USA, UK and EU. Following 5 charts give the breakdown of these A. Human prescription labels by Country: ...

Color Additive Petitions

September 24, 2022
Standards

FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices Food and Drug Administration (FDA) provides guidance for the...

MHRA Guidance on the use of Real-World Data in Clinical Studies to Support Regulatory Decisions

January 7, 2022
Standards

There are vast amounts of data being collected on patients, for example, in electronic health records (EHR), and disease and patient registries. Such data are commonly called Real World Data (RWD),...

Anti-Infective Drug Products for the Pediatric Population – Guidance from FDA

December 19, 2021
Standards

The US Food and Drug Administration (FDA) issued final guidance to assist sponsors in developing anti-infective drugs for the pediatric population. The guidance provides recommendations for developing...

anti-infective products, antifungals, antiparasitic products, developing anti-infective drugs, development of anti-infective, fda division of anti-infective products, food and drug administration, including antibacterials, pediatric populations

Guiding Principles for Good Machine Learning Practice

October 29, 2021
Standards

The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 10 guiding principles that can...

artificial intelligence and machine learning, fda artificial intelligence, Guiding Principles for Good Machine Learning, Machine Learning-enabled medical devices, Medical Devices