The Louisiana Department of Health is considering subscription-based payments for manufacturers of hepatitis C drugs as a way to control the state’s spending on drugs and to serve more Medicaid…
The HHS Office of Inspector General flagged “questionable billing” and rapid growth in Medicare Part D spending for compounded topical drugs in a report released Thursday. Source: Drug Industry Daily
Drug sponsors may not have to prove that a proposed medicine-assisted therapy helps addicts completely kick opioids but they will have to detail how well it helps cut dependence to…
The Association for Accessible Medicines urged the FDA to clarify its draft guidance on Drug Supply Chain Security Act (DSCSA) waivers by adding an estimated timetable for review decisions. Source:…
The Pharmaceutical Care Management Association is concerned about a proposed rule that could remove safe harbor protections for pharmaceutical company rebates and significantly change how U.S. drug prices are formulated.…
The European Medicines Agency expressed “serious concerns” about drugmakers’ preparedness for the UK’s departure from the European Union in a new report. Source: International Pharmaceutical Regulatory Monitor
The FDA unveiled new draft guidance on nonclinical testing of orally-inhaled drug products that contain nicotine — and Commissioner Scott Gottlieb said the agency plans to release follow-up guidelines later…
AstraZeneca has agreed to pay $110 million to settle two lawsuits filed against it by the state of Texas alleging the pharmaceutical giant deceitfully marketed two of its drug products…
Insys announced Wednesday it reached an agreement with the Justice Department to pay $150 million over five years to settle allegations that it bribed doctors to prescribe its fentanyl sublingual spray…
The FDA issued final guidance Wednesday on dissolution testing for immediate-release solid oral dosage form drugs containing high solubility substances. Source: Drug Industry Daily