Attorney Allyson Mullen says FDA made significant changes to a finalized guidance on using IVDs to aid in diagnosing germline diseases.
FDA reminds drug sponsors of eCTD compliance dates for drug master files and other documents.
The CDER Ombudsman reports a 28% drop in contacts from 2016 to 2017.
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Three drug companies comment on an addendum to an ICH draft guidance on statistical principles for clinical trials.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.