The Official Medicare Set Aside Blog And Information Resource

FDA Approves Non-Opioid Analgesic for Mild to Moderate Pain

FDA, Medicare Set-Aside Blog, Rx/Pharmacy on August 3, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

On July 16th, the FDA approved Orphengesic Forte, a non-opioid combination analgesic for the treatment of mild to moderate pain associated with acute musculoskeletal conditions. The FDA’s approval came earlier than expected, which many have viewed as a reinforcement of the FDA’s commitment to do everything in its power to combat the opioid epidemic. Orphengesic […] Continue

FDA Issues Draft Guidance on Clinical Research with Cannabis and Cannabis-Derived Compounds

FDA, Medical Cannabis, Medicare Set-Aside Blog on July 28, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

Medical cannabis continues to create a host of questions as related to workers’ compensation claims, including the legality of use, particularly as guidance and policies continue to be issued.  On July 21st, the FDA issued draft guidance for clinical research with cannabis and cannabis-derived compounds. The guidance does not apply to fully synthetic versions of cannabis, which […] Continue

FDA Approves First Ibuprofen-Acetaminophen Combination Product

FDA, Medicare Set-Aside Blog, Rx/Pharmacy on May 5, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

The FDA has approved the first ibuprofen-acetaminophen combination product, which will be available as an over-the-counter product and marketed under the name of Advil Dual Action. The use of Advil Dual Action is approved for the temporary relief of minor aches and pains due to headache, toothache, backache, menstrual cramps, muscular aches and minor pain […] Continue

COVID-19: Impact on the FDA Pipeline

FDA, Medicare Set-Aside Blog, Rx/Pharmacy on April 15, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

The impact of COVID-19 has undoubtedly been profound, but some of its effects are less obvious than others. One of the impacts associated with the COVID-19 pandemic that may not have hit home yet for many is the likely effect on the pipeline of new drug approvals through the FDA. The pandemic will likely produce […] Continue

FDA Grants OTC Status to Voltaren® 1% Gel

FDA, Medicare Set-Aside Blog, Medicare Set-Asides, Rx/Pharmacy on February 21, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

Last Friday, while many of us may have been focused on Valentine’s Day activities, the Food and Drug Administration (FDA) was busy granting over-the-counter status to three products which were previously available only by prescription. One of those products was Voltaren (diclofenac) 1% gel, which is manufactured by GSK. When the product makes its OTC […] Continue