According to Zachary Brennan of Regulatory Affairs Professionals Society (RAPS), at the recent December FDA/CMS Summit in Washington, DC, Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research (CDER) spoke of 2015 accomplishments and gave a look forward at priorities for 2016.
Accomplishments include 42 new drug approvals, reduction in multiple cycle reviews for generic drugs as companies understand more what they need to provide in applications, new agreements made working with the International Conference on Harmonisation (ICH) on global standards for drugs …and more.
Looking to 2016, the CDER is expected to source talent to fill positions from 680 staff vacancies, negotiate user fee agreements for prescription drug, generic drug and biosimilars … and more.
To view the CDER 2015 accomplishments and 2016 priorities, visit Brennan’s article here. Pearl Pathways is very excited to help you expedite your 2016 life science product development pathways in the New Year. Please contact us.