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.
Pfizer announced that the World Health Organization has granted an expansion to the prequalification of Pfizer’s pneumococcal conjugate vaccine, Prevenar 13, to include adults 50 years of age and older against pneumonia and invasive disease caused by the 13 pneumococcal serotypes contained in the vaccine. The Financial