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 » Antacid Maker Gets Form 483 for Poor Probes Into Bad, Smelly Batches
Antacid Maker Gets Form 483 for Poor Probes Into Bad, Smelly Batches
Brioschi Pharmaceuticals, a maker of antacid products, was handed a Form 483 for lax investigations into out-of-specification lots released to market and complaints of odiferous drugs. Brioschi’s quality control unit failed to further investigate or reject one lot of tartaric acid that tested out of specification and that was later used in more than 30 product lots, the form states. Drug GMP Report