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.
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