Federal Register notice: FDA sends to OMB an information collection extension entitled Establishment Registration and Device Listing for Manufacturers...
New York University bioethicist Arthur Caplan says those calling for greater diversity in clinical trials should clearly explain the benefits of such ...
FDA issues a five-year action plan for fostering and advancing drug development for rare neurodegenerative diseases such as ALS.
FDA grants Novartis accelerated approval for Tafinlar (dabrafenib) plus Mekinist (trametinib) for treating certain patients six years of age and older...
FDA publishes a guidance on clinical pharmacology considerations in assessing food effects in INDs and NDAs.
Federal Register notice: FDA seeks comments on an information collection extension entitled Improving Communication of Important Safety Information 2...
FDA publishes a draft guidance explaining how it periodically assesses drugs that have been granted breakthrough therapy designation and rescinds thos...
University of Illinois psychiatry professor Anand Kumar calls on FDA to closely reevaluate the accelerated approval program to be sure it only uses bi...