The FDA issued its Fiscal Year (FY) GDUFA Science and Research Report last week (read the full report here and the awarded research contracts and grants here). A review of the innovative scientific focus areas helps those of us in the industry to get a sense of where the FDA is headed in support of […]
The use of contract manufacturers for the production of approved drug products has become more and more commonplace, particularly with the steady increase through the years of virtual pharmaceutical companies, a business model where the majority of the drug development and production work is outsourced to third parties as needed. While the use of a […]
February 14, 2020 could be called a red letter day in the world of Rx-to-OTC switch. After a long period of drought, FDA announced that they have approved the Rx-to-OTC switch of three prescription drugs. Please see the announcement here. The three drugs are: Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for the temporary […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
While California is usually a very progressive state, I believe that Governor Newsom did not quite understand the implications of the bill he signed into law banning pay-for delay patent settlements. I believe he failed to see that not all pay-for-delay cases are anticompetitive. According to the Association of Accessible Medicines (AAM) statement about the […]
Each year, the Association for Accessible Medicines (AAM) publishes its report on generic drug savings (here). The data is based on the independent IQVIA organization’s findings. Some interesting findings in the forty-page report are outlined below: 93% of generic prescriptions are filled at $20 or less. The average co-pay of for a generic product covered […]
