FDA Adds Restrictions, Updates Labeling for Breast Implants
The FDA has approved new labeling requirements for all legally marketed breast implants that include a Boxed Warning, patient decision checklist, and other safety measures.
Women’s Health
FDA Clears Updates to Jada System, a Device to Control Postpartum Hemorrhage
The Jada System is comprised of an intrauterine device that utilizes low level vacuum to induce normal contraction of the uterus.
Tymlos Label Update Highlights Bone Building Mechanism of Action
The update is based on data from an open-label, single-arm histomorphometry study.
Osteoporosis Treatments Compared to Assess Effects on Bone Mineral Density
The network meta-analysis compared the effects of 9 osteoporosis drugs on BMD.
FDA to Review Relugolix Combination Therapy for Endometriosis Pain
The application is supported by data from the phase 3 SPIRIT program, which includes the SPIRIT 1 and SPIRIT 2 studies, as well as an open-label extension study.
Mirena Approved for Pregnancy Prevention for Up to 7 Years
By the end of the 7th year, Mirena should be removed and replaced at the time of removal with a new system if continued use is desired.
CDC: COVID-19 Vaccination Recommended for Pregnant People
The recommendation aligns with that from the American College of Obstetricians and Gynecologists and the Society for Maternal Fetal Medicine.
Clindamycin Vaginal Gel Gets Priority Review for Bacterial Vaginosis
The product is designed as a one-time vaginally administered treatment.
Trichomoniasis Treatment: Is it Reinfection or Resistant Infection?
Trichomoniasis is often asymptomatic and, if left untreated, can result in preterm delivery and other adverse pregnancy outcomes and an increased risk for pelvic inflammatory disease and HIV infection.
