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.
The FDA has approved Auxilium Pharmaceuticals’ Xiaflex biologic injection for Peyronie’s disease, a deformity of the penis caused by a lump of plaque that results in a curvature of at least 30 degrees.
There is speculation that around 100 jobs are to be lost at Merck Sharp and Dohme in Brinny in Co Cork. Staff at the pharmaceutical plant near Inishannon has been called to a meeting at which details will be announced. Irish Examiner