Regulatory

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.

Innovation comes with hefty price tag as biopharma R&D spend climbs

To keep biopharmaceutical innovation churning requires mountains of cash. Companies will need to invest as much as $2.5 billion over a 10- to 15-year period in order to bring a new therapy to the marketplace, according to a 2014 study conducted by the Tufts Center for the Study of Drug Development.

Reprocessing endoscopes: what is the true cost?

After investigations found hundreds of patients may have been exposed to antibiotic-resistant superbugs in procedures using a complex endoscope, several national standard-setting organizations updated their device reprocessing guidelines. The Society of Gastroenterology Nurses and Associates, Association of Perioperative Registered Nurses, and Association for the Advancement of Medical Instrumentation all issued new recommendations in areas including personal protective equipment (PPE), manual cleaning, visual […]