FDA releases a draft guidance on the procedures for ANDA applicants to resolve scientific or regulatory disputes with FDA at the agency division level...
FDA says it is working with Baxter Healthcare to temporarily import some IV products manufactured at Baxters plant in Ireland to address shortages cau...
FDA publishes a draft guidance on the content and format of REMS documents, revising a 2009 draft guidance.
FDA commissioner Scott Gottlieb says he believes he can most effectively serve the Trump administration as FDA commissioner rather than as HHS secreta...
Janssen Biotech files an NDA for apalutamide, an investigational, next-generation oral androgen receptor inhibitor for men with non-metastatic castrat...
Philips North America agrees to a consent decree with FDA that will see the company suspending external defibrillator manufacturing at its Andover, MA...
Stakeholders ask for additional clarification and changes in an FDA draft guidance on CMC postapproval manufacturing changes for specified biological ...
CDERs Judy Staffa says the agency has awarded two contracts to organizations to help it better determine how well abuse-deterrent opioids are preventi...