Today, the United States District Court for the Eastern District of Virginia entered a consent decree of permanent injunction between the United States and Henry’s Farm, Inc., located in Woodford, Virginia, and its owner Soo C. Park, after the U.S. Food and Drug Administration documented multiple violations of federal food safety laws and regulations. The consent decree prohibits Henry’s Farm, Inc. from receiving, processing, manufacturing, preparing, packing, holding and distributing ready-to-eat soybean and mung-bean sprouts. The U.S. Department of Justice sought the consent decree on behalf of the FDA.

As an additional safety measure against the emerging Zika virus outbreak, the U.S. Food and Drug Administration today issued new guidance for immediate implementation providing recommendations to reduce the potential transmission risk of Zika virus from human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance addresses donation of HCT/Ps from both living and deceased donors, including donors of umbilical cord blood, placenta, or other gestational tissues.

The U.S. Food and Drug Administration announced today two actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization. These actions include a new, mandatory clinical study for Essure to determine heightened risks for particular women and draft guidance with labeling recommendations including a boxed warning label and a checklist for doctors to discuss potential risks of implanted permanent birth control devices with patients. Since Essure’s approval in 2002, the agency has continued to monitor Essure’s safety and effectiveness by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency. The new actions announced today take additional steps and follow the agency’s careful evaluation of available information.

The U.S. Food and Drug Administration announced today two actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization. These actions include a new, mandatory clinical study for Essure to determine heightened risks for particular women and draft guidance with labeling recommendations including a boxed warning label and a checklist for doctors to discuss potential risks of implanted permanent birth control devices with patients. Since Essure’s approval in 2002, the agency has continued to monitor Essure’s safety and effectiveness by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency. The new actions announced today take additional steps and follow the agency’s careful evaluation of available information.

The U.S. Food and Drug Administration today announced the availability of $2 million in research grants to fund natural history studies in rare diseases. The aim is to collect data on how specific rare diseases progress in individuals over time so that knowledge can inform and support product development and approval. This will be the first time the FDA will provide funding through its Orphan Products Grants to conduct these types of studies for rare diseases.

The U.S. Food and Drug Administration today announced the availability of $2 million in research grants to fund natural history studies in rare diseases. The aim is to collect data on how specific rare diseases progress in individuals over time so that knowledge can inform and support product development and approval. This will be the first time the FDA will provide funding through its Orphan Products Grants to conduct these types of studies for rare diseases.