Halloran Chief Operating Officer, Greg Dombal, has been featured in an article published online by Nature Medicine about FDA's use of the 'breakthrough' designation, which was just awarded for the first time last month. Greg's expertise in regulatory guidelines and submissions lent itself well to the discussion.
First 'breakthrough' drugs designated, but dilution worries linger by Elie Dolgin
As published in Nature Medicine 19, 116–117 (2013).
Please click here to read the article in its entirety online.