FDA Roundup: October 31, 2023
Retrieved on:
Tuesday, October 31, 2023
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The FDA remains committed to collecting and providing updates on the long-term safety and effectiveness information about Essure, a permanently implanted birth control device for women.
Key Points:
- The FDA remains committed to collecting and providing updates on the long-term safety and effectiveness information about Essure, a permanently implanted birth control device for women.
- Although Essure has not been available for implantation in the United States since December 2019, the FDA continues to monitor the product's safety through an FDA-required postmarket surveillance ("522") study and other activities.
- The master file was submitted by Steris Corporation, Sterilization for Medical Devices | FDA .
- The FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.