FDA and the HHS Office for Human Research Protections issue a guidance on Minutes of Institutional Review Board (IRB) Meetings.
Federal Register notice: FDA publishes a list of premarket approval applications that have been approved from 7/1/2016 through 6/30/2017.
FDA updates a 2016 safety alert to transplant surgeons and cardiologists about additional data that continue to indicate that there is a higher mortal...
FDA and several ophthalmic-related medical associations announce a 10/23 workshop entitled Ophthalmic Digital Health to discuss factors to consider wh...
FDA makes available a guidance on Expedited Programs for Serious Conditions Drugs and Biologics.
FDA deploys additional staff to Puerto Rico to work with pharmaceutical and device companies to prevent shortages of medically necessary drugs and dev...
FDA Review posts the Federal Register notices for the week ending 9/22/2017.
Federal Register notice: FDA seeks comments on a information collection extension for its Certification To Accompany Drug, Biological Product, and Dev...