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P&T September 2018
Money Needed to Dig FDA Out of Its Review Ditch
Questions about the safety and efficacy of cough and cold medicines and numerous other over-the-counter (OTC) products—along with an overwhelmed, understaffed FDA—are the driving force behind Congressional action to put a first-ever OTC user fee program in place.
Health Care & Law
Despite a slow legislative start by President Trump, new federal and state regulatory health care changes will have important implications for pharmacists, P&T committees, and patients.
Epithelial ovarian cancer is the leading cause of death due to a gynecological malignancy in the United States. The authors review the pharmacology, safety, efficacy, and role of poly adenosine diphosphate [ADP]-ribose polymerase (PARP) inhibitors in the treatment and maintenance of relapsed, advanced ovarian cancer.
We review key sessions on multiple myeloma, chronic lymphocytic leukemia, Hodgkin lymphoma, Epstein-Barr virus-positive post-transplant lymphoma, and follicular lymphoma.
Part 1 of a 3-part series discusses 3 medication safety risks that can easily fall off the radar screen in hospitals and doctors’ offices.
President Trump’s American Patients First plan to reduce drug prices has some innovative aspects but might face political roadblocks.
Approvals, new indications, regulatory activities, and more
Baricitinib (Olumiant) tablets for rheumatoid arthritis; plazomicin (Zemdri) injection for complicated urinary tract infections; and cannabidiol (Epidiolex) oral solution for seizures with Lennox-Gastaut syndrome and Dravet syndrome