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FDA releases a draft guidance on the procedures for ANDA applicants to resolve scientific or regulatory disputes with FDA at the a...[ Price : $8.95]
FDA says it is working with Baxter Healthcare to temporarily import some IV products manufactured at Baxters plant in Ireland to a...[ Price : $8.95]
FDA publishes a draft guidance on the content and format of REMS documents, revising a 2009 draft guidance.[ Price : $8.95]
FDA commissioner Scott Gottlieb says he believes he can most effectively serve the Trump administration as FDA commissioner rather...[ Price : $8.95]
Janssen Biotech files an NDA for apalutamide, an investigational, next-generation oral androgen receptor inhibitor for men with no...[ Price : $8.95]
Philips North America agrees to a consent decree with FDA that will see the company suspending external defibrillator manufacturin...[ Price : $8.95]
Stakeholders ask for additional clarification and changes in an FDA draft guidance on CMC postapproval manufacturing changes for s...[ Price : $8.95]
CDERs Judy Staffa says the agency has awarded two contracts to organizations to help it better determine how well abuse-deterrent ...