by Emily Sparrow | Nov 2, 2015
FDA Center for Drug Evaluation and Research (CDER) recently announced the release of a new case study, “Drug Approval: Bringing a New Drug to the Market,” to accompany their efforts of advancing the knowledge of drug regulatory processes within the industry. According...
by Emily Sparrow | Nov 2, 2015
Pearl Pathways will be presenting and exhibiting at the ACRP 15th annual fall symposium about excellence in research. The event will be held at the Sheraton Hotel in Indianapolis on November 6th, from 7:30AM-5:15PM. Pearl Pathways’ speakers include Gretchen Bowker,...
by Emily Sparrow | Oct 23, 2015
Recently, Director of the Center for Drug Evaluation and Research at FDA, Janet Woodcock, addressed questions regarding the generic drug user fee act (GDUFA) and whether or not it will provide FDA the means to ensure quality. Woodcock stated that, while it’ll help...
by Emily Sparrow | Oct 16, 2015
Our Asia Pacific partner, Brandwood Biomedical, authored a fantastic report about last month’s China International Medical Device Regulatory Forum (CIMDR) held in Guangzhou, featuring a workshop on Biological Evaluation of Medical Devices. Twelve senior experts from...
by Emily Sparrow | Oct 16, 2015
FDA recently announced the approval of the Acceptability of Draft Labeling to Support ANDA Approval guidance. This new guidance states that it is no longer required to submit a final printed label (FPL) to the Office of Generic Drugs in order to approve Abbreviated...
