Today, the U.S. Food and Drug Administration issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking additional information to help the agency make informed decisions about menthol in cigarettes.
Category Archives: Drug Safety Information Podcasts
FDA permits marketing of first brain wave test to help assess children and teens for ADHD
The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. When used as part of a complete medical and psychological examination, the device can help confirm an ADHD diagnosis or a clinician’s decision that further diagnostic testing should focus on ADHD or other medical or behavioral conditions that produce symptoms similar to ADHD.
FDA proposes “action level” for arsenic in apple juice
The U.S. Food and Drug Administration today proposed an “action level” of 10 parts per billion (ppb) for inorganic arsenic in apple juice. This is the same level set by the U.S. Environmental Protection Agency (EPA) for arsenic in drinking water.
FDA approves new treatment for a type of late-stage lung cancer
The U.S. Food and Drug Administration today approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.
FDA permits marketing of quicker method for checking effectiveness of medical device steam sterilization
The U.S. Food and Drug Administration today allowed marketing of the Verify Cronos Self Contained Biological Indicator (SCBI), a new test that can help speed the determination of whether steam sterilization of reusable medical devices is effective.
FDA, Justice Department takes action against Vermont dairy farm
The U.S. Food and Drug Administration has announced that the United States District Court for the District of Vermont entered a consent decree of permanent injunction against Lawson Farm of Irasburg, Vermont, its owner, Robert Lawson, and its manager, George R. Lawson, for selling cows and bull calves for human food that contain illegal drug residues in violation of federal law.
FDA to detain pomegranate seeds offered for import from Goknur of Turkey
The U.S. Food and Drug Administration will detain shipments of pomegranate seeds from Goknur Gida Maddeleri Ithalat Ihracat Tic (Goknur Foodstuffs Import Export Trading) of Turkey when they are offered for import into the United States.
FDA approves the first non-hormonal treatment for hot flashes associated with menopause
The U.S. Food and Drug Administration today approved Brisdelle (paroxetine) to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective serotonin reuptake inhibitor paroxetine mesylate, is currently the only non-hormonal treatment for hot flashes approved by the FDA.
Federal judge enters consent decree with Med Prep Consulting
A federal judge from the U.S. District Court for New Jersey has entered a consent decree of permanent injunction against Med Prep Consulting, Inc., a pharmacy licensed by the state of New Jersey, and Gerald R. Tighe, the company’s president and owner. The U.S. Department of Justice sought the consent decree on behalf of the U.S. Food and Drug Administration.
FDA takes action to protect consumers from dangerous medicines sold by illegal online pharmacies
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers. These actions include the issuance of regulatory warnings, and seizure of offending websites and $41,104,386 worth of illegal medicines worldwide.