First Amendment, patient engagement on CDER's list

In a (see BioCentury, Dec. 10, 2012).

Among many other priorities, Woodcock listed patient engagement. In addition to public meetings with patients, the center is developing a quantitative benefit-risk assessment template that incorporates burden of disease. Woodcock noted that patients are "experts" on chronic diseases, and described the challenges in integrating their views into regulations of thousands of diseases. ...