EC to hold major forum on borderline issues:
This article was originally published in Clinica
Growing concerns at the European Commission about how to regulate products that are increasingly being hybridised between various regulatory sectors are to be addressed in a major conference after the summer break. A landmark conference on borderline issues, involving Commission services in medical devices, pharmaceuticals, cosmetics, biotechnology, food and blood products, is due to be held in September or October. It will be targeted at representatives from industry as well as regulatory authorities. Few details are as yet available.
You may also be interested in...
House and Senate Democrats sponsor legislation to authorize FTC enforcement against sales of "consumer goods and services at an unconscionably excessive price during the" COVID-19 pandemic. "It’s outrageous that some companies and individuals are taking advantage of consumers by price-gouging," says Energy and Commerce Committee Chairman Frank Pallone.
Robert Califf, a former FDA commissioner turned Verily Life Sciences exec, is just one of the voice predicting a long-term impact on clinical trial processes from the COVID-19 outbreak.
A US National Academies meeting on digital health technology showcased the communication gap between regulators and tech developers when it comes to important concepts like “digital biomarkers.”