CDER publishes "Review" of the Year 2012

On 10 December 2012, Dr Trockmorton, Deputy Director for Regulatory Programs of the Center for Drug Evaluation and Research presented the most important aspects for the Agency in 2012. First, he introduced his presentation with the pressure on the CDER which he summarised in risk-benefit balances between the FDA, the industry and the patients. Yet, safety aspects of medicinal products play an important role for the CDER.

Dr Trockmorton also presented the number of people employed at CDER: 3,335 employees. 2,608 of them are scientists. He further detailed the composition: 449 are MDs, 401 are pharmacologists/toxicologists, 346 are chemists, and 163 are statisticians. The topic "Drug Shortages" is one of the few GMP-related aspects included in the presentation, although this topic - which also may be due to GMP deficiencies from the manufacturer - more than doubled between 2005 and 2011. The CDER wants to strengthen the addressing of this issue.

Further details can be found in the presentation "CDER Priorities 2012".