Five stakeholders respond to the FDA Oncology Center of Excellence listening session with recommendations for improvements to the organizational struc...
Three drug companies comment on an addendum to an ICH draft guidance on statistical principles for clinical trials.
Cooper Union professor William Hyman questions how useful the unique device identifier database will be in identifying medical devices.
CDERs Dominic Chiapperino is promoted from Controlled Substances Staff acting director to director.
FDA Review posts the latest Federal Register notices for the week ending 4/27/2018.
FDA releases charts giving statistics on the number of human cell and tissue product inspections in FY 2013-2017 with their results.
FDA publishes a list of Medication Guides with six new guides and 30 updated since 3/2017.
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...