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 Sets Dec. 1 GDUFA Self-Identification Deadline
FDA Sets Dec. 1 GDUFA Self-Identification Deadline
Generic-drug makers must submit self-identification information to the FDA by Dec. 3 to comply with the recently passed Generic Drug User Fee Amendments of 2012. Facilities that fail to self-identify will have their products labeled as misbranded, according to a Federal Register notice scheduled to publish Oct. 2. Drug Industry Daily