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 » FDA: NECC Failed to Fix Problems After Early Warning Signs
FDA: NECC Failed to Fix Problems After Early Warning Signs
The New England Compounding Center (NECC), at the heart of a nationwide fungal meningitis outbreak, dropped the ball after seeing early signs of unacceptable levels of microbial contamination, the FDA says. The NECC’s own environmental monitoring found mold and bacteria in multiple locations earlier this year, including on surfaces in clean rooms used to produce sterile steroid injections, an Oct. 1 to Oct. 26 inspection found. Drug Industry Daily