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 » Hospira Reports ‘More Issues’ Than Previously Thought, Some Progress in Manufacturing Remediation
Hospira Reports ‘More Issues’ Than Previously Thought, Some Progress in Manufacturing Remediation
Amid lingering quality issues at a number of its manufacturing plants, Hospira reported some success in its discussions with the FDA but notes there are more trouble spots than the company previously thought. “We are trying to drive to the surface all the issues we can in 2012 and take care of them,” Thomas Werner, chief financial officer, said during the company’s second-quarter conference call. Drug Industry Daily