On 10 December 2012, Dr Trockmorton, Deputy Director for Regulatory Programs of the FDA Centers for Drug Evaluation and Research (CDER) presented the most important aspects for the Agency in 2012. Read more here.
Five new documents have been published by the EMA for manufacturers of veterinary medicinal products, including the VICH Guideline Draft on Statistical Evaluation of Stability Data. Read more here about these documents published for veterinary use.