The HHS Inspector General says opioid use in Medicare Part D is decreasing and use of medication-assisted treatment is increasing.
U.S. WorldMeds asks FDA not to approve any ANDA for a generic version of its Apokyn that covers only the drug portion of the drug-device combination.
FDA clears a Biotronik 510(k) for the Biomonitor III injectable cardiac monitor.
K&L Gates attorneys look at the current status and impact of two Justice Department guidances involving False Claims Act whistleblower cases.
FDA warns U.S. Pharmaceuticals about CGMP violations in its manufacturing of finished pharmaceuticals.
Federal Register notice: FDA withdraws approval of 11 NDAs from multiple applicants because the products are no longer marketed.
Federal Register notice: FDA withdraws approval of DHL Laboratories NDA for dextrose injection because the company has repeatedly failed to file requi...
Federal Register notice: FDA makes available an immediately in effect guidance entitled Compliance Policy for Certain Compounding of Oral Oxitriptan (...