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.
Home » Branan Medical Gets Closeout Resolving Clearance Concerns
Branan Medical Gets Closeout Resolving Clearance Concerns
Branan Medical, a maker of drug testing kits, received an FDA closeout letter resolving myriad marketing clearance and manufacturing concerns cited in a 2009 warning letter. Corrective action taken by Branan in response to the agency’s Dec. 28, 2009, warning letter “appears” to have resolved the company’s lack of an approved PMA application or IDE application noted at the time, the FDA said in a recently posted closeout letter. The GMP Letter