In a new programme starting on 15 September 2009, the FDA intends to set the timeframe for statements and responses to a 483 to a maximum of 15 business days. Read more about the new programme.
The European Medicinces Agency (EMEA) has published a new Guideline on Replacement of the Rabbit Pyrogen Testing by an Alternative Testing for Plasma derived Medicinal Products to provide a possibility to cover detection gaps like fever inducing cytokines. Read more here.