The Justice Department says an Ohio doctor and an Avanir Pharmaceuticals employee have pleaded guilty to their roles in a drug kickback scheme.
Radius Health files a supplement to its earlier Tymlos petition with three additional actions it wants FDA to take.
Cardiac surgeon Hooman Noorchashm petitions the agency asking it to change the classification of Becton Dickinsons poly 4-hydroxybutyrate (P4HB)-based...
Six Republican lawmakers urge FDA commissioner Robert Califf to update them about an ongoing delay to review Floridas proposed Canadian Prescription D...
Two stakeholders comment on an FDA workshop on advancing premarket safety analytics.
FDA warns Amazon.com it is distributing unapproved new drugs.
FDA warns Fort Worth, TX-based Sovereign Pharmaceuticals about CGMP violations in its manufacturing and distribution of an unapproved biologic product...
Two drug stakeholder associations raise questions and suggest changes to an International Council for Harmonization draft guidance on pediatric extrap...
