The U.S. District Court for the Eastern District of California entered a consent decree of permanent injunction on Friday, June 24, 2016, between the U.S. Food and Drug Administration and Wa Heng Dou-Fu & Soy Sauce Corporation requiring the business to immediately cease manufacturing and distributing food until it comes into compliance with federal food safety laws.
Category Archives: Drug Safety Information Podcasts
FDA approves AspireAssist obesity device
The U.S. Food and Drug Administration today approved a new obesity treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal.
FDA approves AspireAssist obesity device
The U.S. Food and Drug Administration today approved a new obesity treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal.
FDA approves vaccine to prevent cholera for travelers
The U.S. Food and Drug Administration today approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas. Vaxchora is the only FDA-approved vaccine for the prevention of cholera.
FDA targets unlawful internet sales of illegal prescription medicines during International Operation Pangea IX
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, announced that it took action this week against 4,402 websites that illegally sell potentially dangerous, unapproved prescription drugs to U.S. consumers. This effort was part of Operation Pangea IX, the Ninth Annual International Internet Week of Action (IIWA), a global cooperative effort, led by INTERPOL, to combat the unlawful sale and distribution of illegal and potentially counterfeit medical products on the internet.
Statement on HHS OIG Early Alert on FDA food recall initiation process
Public health is our top priority and the U.S. Food and Drug Administration works hard to ensure the U.S. food supply remains among the safest in the world.
Statement from FDA Commissioner Robert Califf, M.D. on the release of the final individual patient expanded access form
Today, the U.S. Food and Drug Administration finalized its efforts to streamline the process used by physicians to request expanded access, often called “compassionate use,” to investigational drugs and biologics for their patients. As a physician, I understand the importance of being able to access investigational treatments for a patient when there are no other options to treat their serious disease or condition.
FDA approves new diagnostic imaging agent to detect rare neuroendocrine tumors
The U.S. Food and Drug Administration today approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors (NETs).
FDA approves new diagnostic imaging agent to detect rare neuroendocrine tumors
The U.S. Food and Drug Administration today approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors (NETs).
FDA takes action against Kansas food manufacturer for repeated food safety violations
The U.S. District Court for the District of Kansas entered a consent decree of permanent injunction today between the United States and Native American Enterprises, LLC, located in Wichita, Kansas; its part-owner, William N. McGreevy; and its production manager, Robert C. Conner.