Overhaul of New Drug Approval Process Moves Forward

Overhaul of New Drug Approval Process Moves Forward

Source: 
Pharma
snippet: 

Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), aims to start implementing new review practices in the Office of New Drugs (OND) by the end of 2018 and to stand up a new OND structure by the summer of 2019, but has to overcome numerous hurdles in the process. A first order of business is to select a new OND director, she told members of the Alliance for a Stronger FDA at a recent briefing, a position that Woodcock has assumed temporarily while the reorganization process has proceeded.