On October 1, 2026, the “FDA approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease”. What makes this implantable heart valve device so special is that it can be adjusted in size as the child grows and, as a result, potentially eliminates the need for […]
During Dr. Heidi Overton’s confirmation hearings, she did not answer all of the questions directly asked of her, like would she bend to the President if she strongly disagreed with his position based on medical grounds. There were also questions regarding the abortion pill and vaccines where her answers took (what one might call) a […]
While not yet available in pharmacies, Onswik (insulin efsitora alfa-gobe) injection for subcutaneous use was approved by FDA on September 23, 2026. So, what’s new? This is a once weekly injectable insulin (instructed to be injected on the same day of the week), which according to the Lilly webpage here (and also by my own […]
In our global industry, the FDA does not want to fall behind countries like China and Australia where first in human studies have an expedited pathway. Operation Trialblazer is designed in part to do that for US companies. It is described by HHS and FDA as an “initiative to modernize and accelerate clinical drug development […]
CDER published a study titled “First-Cycle Complete Response Rates for CDER NDA and BLA Applications” (here). I read and reread it a few times and I am still confused. It appears that FDA published this report to counter industry’s stated belief that the number of Complete Response Letters (CR) have increased over time. This is […]
Just like the new season of Slow Horses premiering in September on Apple TV, it appears that September is also starting out to be a “slow” approvals action month at OGD. With this being midway through the last month of FY 2026, thus far through September 15th, OGD posted only 17 full approval actions and […]
The AAM 2026 Savings Report, developed in partnership with IQVIA, was released yesterday (here) which describes the tremendous savings that the American consumer has realized from generic drug products and biosimilars. With generics accounting for 89% of all prescriptions dispensed and the uptake of biosimilars increasing, the savings are sure to compound. The facts speak […]
FDA announced today (here) that, after reviewing timely submitted comments to its September 27, 2021 notice of availability of the proposed order OTC000008 titled Amending Over-the-Counter (OTC) Monograph M020, that it is removing two ingredients, para-aminobenzoic Acid (PABA) and trolamine salicylate from the monograph. The notice states that “FDA has determined that there are no […]
Today, on the Federal Register’s pre-publication page, the FDA published the new fee that must be submitted for use of a priority review voucher. The notice (here) establishes the “FY 2027 priority review fee rate for use of tropical disease, rare pediatric disease, and material threat MCM priority review vouchers at $1,798,596” (the FY 2026 […]
The U.S. Food and Drug Administration announced that it is taking action to help address a potential supply gap of neonatal starter parenteral nutrition (PN). These products provide essential nutrients through an IV to premature and critically ill newborns who cannot receive nutrition by mouth or through a feeding tube. The FDA has issued an […]
