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.
Archive for the ‘Drug Recalls & Safety Notices’ category
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 […]
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 […]
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.
FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer
The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients. Such mutations are present in approximately 10-20 […]
FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer
The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients. Such mutations are present in approximately 10-20 […]
FDA issues draft guidance to food industry for voluntarily reducing sodium in processed and commercially prepared food
Today, the U.S. Food and Drug Administration issued draft guidance for public comment that provides practical, voluntary sodium reduction targets for the food industry. Average sodium intake in the U.S. is approximately 3,400 mg/day. The draft short-term (two-year) and long-term (10-year) voluntary targets for industry are intended to help the American public gradually reduce sodium […]
FDA approves Ocaliva for rare, chronic liver disease
Today the U.S. Food and Drug Administration granted accelerated approval for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a single therapy in adults unable to tolerate UDCA.
FDA approves Zinbryta to treat multiple sclerosis
The U.S. Food and Drug Administration today approved Zinbryta (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a long-acting injection that is self- administered by the patient monthly.
FDA approves new diagnostic imaging agent to detect recurrent prostate cancer
The U.S. Food and Drug Administration today approved Axumin, a radioactive diagnostic agent for injection. Axumin is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment.
FDA approves first buprenorphine implant for treatment of opioid dependence
The U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.
FDA issues final food defense regulation
The U.S. Food and Drug Administration today finalized a new food safety rule under the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) that will help to prevent wide-scale public health harm by requiring companies in the United States and abroad to take steps to prevent intentional adulteration of the food supply. While such acts […]
FDA modernizes Nutrition Facts label for packaged foods
FDA modernizes Nutrition Facts label for packaged foods
FDA modernizes Nutrition Facts label for packaged foods
FDA modernizes Nutrition Facts label for packaged foods