A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
In a boost for Big Pharma, the European Medicines Agency (EMA) has raised the fee-reduction rate for non-small and medium-sized enterprises (SMEs) seeking assistance on non-pediatric-related protocol from 40 percent to 75 percent, in line with recommendations by the agency’s orphan medicinal products panel.
Respironics’ Trilogy 100, 200 and 202 ventilators are being recalled because of defects in their power supply components. If the power supply stops, a ventilator may abruptly cease functioning. The recall affects ventilators made between Jan. 1 and April 27 of this year. Respironics, which initiated the Class I recall, is asking customers to return the affected products for replacement. The GMP Letter