New Drug Submission Rules: A How-To

Posted: 07/24/16

The FDA has mandated that by May 2017 all new drug applications must be submitted electronically in a format called eCTD. For drug developers to comply, they will need new tools, workflows, and publishing strategies. PAREXEL is a leading international drug consulting firm, and the Bloom Group helped PAREXEL Director Steven Dowdley and Senior Director Chet Shemanski place their article, “Accelerating Submissions With a Six-Point eCTD Strategy,” in the online journal of the Regulatory Affairs Professionals Society (RAPS), here.