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.
Valencia, Calif.-based SetPoint Medical has hired Sagentia to develop a programming interface for a neuromodulation device designed to provide a lower-cost and lower-risk alternative to immunosuppressive drugs such as prednisone that treat chronic inflammatory diseases such as Crohn’s disease and rheumatoid arthritis.
The European Commission Dec. 5 granted AstraZeneca (AZ) European marketing permission for its Fluenz Tetra live attenuated intranasal influenza vaccine for patients age 2 to 18. The vaccine is sprayed into each nostril, where its weakened viral strains induce protective immunity.
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