The U.S. Food and Drug Administration today issued an updated safety communication warning health care providers and patients that surgical placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to greater risk than other surgical options.
Category Archives: Food & Drug Recalls
FDA seeks comment on proposed policy for diagnostic tests used with targeted drug therapies
The U.S. Food and Drug Administration today issued a new draft guidance to facilitate the development and review of companion diagnostics – tests used to help health care professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give. The draft document is intended to provide companies with guidance on the agency’s policy for reviewing a companion diagnostic and the corresponding therapy.
FDA approves Boostrix to prevent tetanus, diphtheria, and pertussis in older people
The U.S. Food and Drug Administration today approved Boostrix vaccine to prevent tetanus, diphtheria, and pertussis (whooping cough) in people ages 65 and older.
Posh Bakery Issues Allergy Alert on Undeclared Eggs in Butter Mini Croissants and Chocolate Mini-Croissants
Posh Bakery of Santa Clara, CA is recalling all its Butter Mini Croissants and Chocolate Mini-Croissants due to use of an egg wash that was undeclared on the product label. People who have allergies to eggs run the risk of serious or life-threatening reactions if they consume this product.
FDA proposes new policy for some diagnostic and radiology devices
The U.S. Food and Drug Administration issued a draft guidance today describing its intent to exercise enforcement discretion with respect to the premarket notification requirements for certain in vitro diagnostic and radiology devices with well-established safety and effectiveness profiles.
FDA approves Xarelto to reduce risk of blood clots after hip, knee replacements
On July 1, the U.S. Food and Drug Administration approved Xarelto (rivaroxaban) to reduce the risk of blood clots, deep vein thrombosis (DVT), and pulmonary embolism (PE) following knee or hip replacement surgery.
FDA issues anti-smuggling strategy and draft guidance on new dietary ingredients
The U.S. Food and Drug Administration today announced that it has completed two tasks required by the new Food Safety Modernization Act (FSMA) and that new authorities to suspend the registration of food facilities and to administratively detain food that it has reason to believe are adulterated or misbranded have gone into effect.
Evergreen Fresh Sprouts, LLC Voluntarily Recalls Alfalfa Sprouts and Spicy Sprouts Because Of Possible Health Risk
Moyie Springs, Idaho-Evergreen Fresh Sprouts, LLC announced a voluntary recall of Alfalfa Sprouts and Spicy Sprouts because it has the potential to be contaminated with Salmonella. The recalled sprouts have been linked to a multistate outbreak of Salmonella infections.
Read The Complete Story!
FDA, Justice Department take action against California calf hauler
The U.S. Food and Drug Administration has announced that the United States District Court for the Eastern District of California, Sacramento Division, entered a consent decree of permanent injunction against John C. Virtue, doing business as Virtue Calves, and Shannon L. Virtue for selling veal calves for use as food that contain illegal drug residues in violation of federal law.
FDA approves Arcapta Neohaler to treat chronic obstructive pulmonary disease
The U.S. Food and Drug Administration today approved Arcapta Neohaler (indacaterol inhalation powder) for the long term, once-daily maintenance bronchodilator treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.