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 » HHS Chief Sebelius Backs Early Reporting Requirement for Shortages
HHS Chief Sebelius Backs Early Reporting Requirement for Shortages
The FDA and HHS have done all they can administratively to curb drug shortages and now need additional help from Congress, HHS Secretary Kathleen Sebelius told lawmakers Feb. 15. The health chief told the Senate Finance Committee the FDA would strongly benefit from pending bills, S. 296 and H.R. 2245, that would mandate six months notification by drugmakers discontinuing, interrupting or adjusting manufacture of a drug known to be in short supply. Generic Line