FDA

Device Advice! The Value and Use of PRO Measures in Assessing Medical Devices

The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has issued its first report on patient reported outcomes (PRO) in premarket submissions and post market studies of medical devices . The report outlines the many steps that are being implemented by the FDA to meet the significant increase in PRO data […]

Everything old is new again: bacteriophage therapy

According to conventional wisdom, if you let children play in the dirt, they get sick less frequently. As is often the case, science appears to back up this homespun theory. Now that many disease-inducing pathogens are developing antibacterial resistance, scientists and medical professionals are looking for answers that may literally be beneath their feet. Bacteriophages […]

The impact of the changing regulatory environment on the approval of new medicines, 2007-2016

Over the last decade, 2007-2016, convergence in approval times as well as changes in strategies of multinational pharmaceuticals have resulted in more new active substances (NASs) being internationalized, referring here to receiving marketing authorization in six major regulatory agencies, namely the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), the Japan Pharmaceuticals […]

The shifting regulatory landscape impacts the review of new medicines

Major improvements in the regulatory environment in the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) countries over the last decade has led to a decrease in the time to approval as well as an increase in the number of medicines that have become available.