Federal Register notice: FDAs Dermatologic and Ophthalmic Drugs Advisory Committee meets 10/13 to review intraocular pressure drug.
Four FDAers analyze the agencys response to individual drug expanded-access requests over a four-year period and find that 98% were allowed to proceed...
The 5th Circuit Court of Appeals upholds a Texas federal court ruling granting summary judgment to Solvay Pharmaceuticals in a whistleblower False Cla...
FDA releases a draft guidance on statistical approaches to evaluating analytical similarity between biosimilars and their reference products.
An FDA safety alert warns that Intercept Pharmaceuticals liver disease drug Ocaliva (obeticholic acid) is being incorrectly dosed in some patients wit...
FDA clears a Brainlab 510(k) for Elements Spine SRS and Elements Cranial SRS, two software applications that aid in the patient-tailored planning of r...
Stakeholders offer FDA a variety of perspectives on how well the Waxman-Hatch amendments balance innovation and access.
FDA says that opioid addiction medications buprenorphine and methadone should continue to be given to patients taking benzodiazepines or other drugs d...