Late reporting was concentrated among a small number of manufacturers, with 3 manufacturers and 13 devices accounting for 54.8% of all late reports between 2019 and 2022.
Maternal age distribution shifts dramatically as overall birth rates continue a 30-year decline, with women younger than 30 now accounting for less than half of all births, and an increase of older mothers.
February's FDA approvals feature advancements in cardiology, neurology, infectious diseases, and rare disorders, including the first trials for genetically modified pig kidney transplants and novel treatments for Parkinson’s disease and spinal muscular atrophy.
The FDA has approved Miudella, a hormone-free copper IUD, for pregnancy prevention for up to three years, marking the first approval of a new copper IUD in the U.S. in over 40 years.
The U.S. FDA has recommended new labeling changes for testosterone products based on clinical and post-market studies related to blood pressure and cardiovascular effects.