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 » Lax Investigations Into Discrepancies Lands A&Z Pharmaceutical a Form 483
Lax Investigations Into Discrepancies Lands A&Z Pharmaceutical a Form 483
A&Z Pharmaceutical failed to adequately investigate unexplained discrepancies in drug products tied to compression-related troubles at the company’s Deer Park, N.Y., plant, a Form 483 states. Thorough investigations of “black spots” and “dirt specks” discovered during compression of acetaminophen tablets were not conducted, FDA investigators said in the Nov. 15, 2011, form. Drug GMP Report