CDER issues a Manual of Policies and Procedures specifying how and when the Office of Pharmaceutical Quality will grant or deny a request for an exped...
FDA advisors say that a post-marketing study shows that Pfizers Celebrex has cardiac safety risks that are comparable to prescription ibuprofen and na...
Federal Register notice: FDA makes available a guidance entitled The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.
Federal Register notice: FDA makes available a draft guidance entitled Multiple Function Device Products: Policy and Considerations.
Federal Register notice: FDA makes available a guidance entitled Clinical Trial Imaging Endpoint Process Standards.
FDA commissioner Scott Gottlieb says the agencys new internal data science incubator is one of many steps being taken to implement its digital innovat...
CDER Office of Testing and Research senior staff fellow Xiaoming Xu outlines steps being taken to advance nanotechnology in drug development, along wi...
FDA commissioner Scott Gottlieb is pleasing everyone on Capitol Hill, reports Alliance for a Stronger FDA deputy executive Steven Grossman in an analy...