Dongying Tiandong Receives Warning Letter
French regulators have raised concerns about heparin made by Chinese supplier Dongying Tiandong Pharmaceutical and called on the EMA to revoke its GMP certificate.
The U.S. Food and Drug Administration (FDA) issued a communication outlining actions on Essure® permanent birth control today, following a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on September 24, 2015. The FDA outlined actions including the collection of additional data and proposed updates to the Essure labeling. Essure is an important permanent birth control option with a positive benefit-risk profile. Bayer will continue to work with the FDA to implement measures to support the continued safe, effective and appropriate use of Essure.
Dongying Tiandong Pharmaceutical Co., Ltd fails EDQM Inspection