The U.S. Food and Drug Administration (FDA) today unveiled the nine graphic health warnings required to appear on every pack of cigarettes sold in the United States and in every cigarette advertisement. This bold measure will help prevent children from smoking, encourage adults who do to quit, and ensure every American understands the dangers of smoking.
Category Archives: Drug Safety Information Podcasts
FDA examines ways to improve consumer understanding of prescription drug ads
Findings from three studies conducted by the U.S. Food and Drug Administration confirm that the way information is conveyed and displayed in printed drug advertising affects consumer understanding of prescription medications.
FDA unveils new global strategy to help ensure safety and quality of imported products
The U.S. Food and Drug Administration today unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain in a report called the “Pathway to Global Product Safety and Quality.”
FDA issues draft guidance for early version of an artificial pancreas system
The U.S. Food and Drug Administration today issued draft guidance that will help advance the development and approval of an artificial pancreas system to treat type 1 diabetes in the United States.
FDA approves first generic versions of the antibiotic levofloxacin to treat certain infections
The U.S. Food and Drug Administration today approved the first generic versions of Levaquin (levofloxacin), an antibiotic approved to treat certain infections in people ages 18 and older.
Levofloxacin is used to treat mild, moderate, or severe bacterial infections of the skin, sinuses, kidneys, bladder, and prostate caused by specific germs. It also is used to treat certain bacterial infections that cause bronchitis or pneumonia, and to treat those exposed to inhalational anthrax.
FDA: California seafood handler enters into consent decree
The U.S. Food and Drug Administration and San Diego-based Ocean Harvest Inc., an outlet for salmon, tuna, and other fresh fish intended for raw consumption, and Ocean Harvest president, Minkyu Park, recently signed a consent decree of permanent injunction. The company had been selling seafood that was handled in violation of federal food safety standards.
FDA approves Nulojix for kidney transplant patients
The U.S. Food and Drug Administration today approved Nulojix (belatacept) to prevent acute rejection in adult patients who have had a kidney transplant. The drug is approved for use with other immunosuppressants (medications that suppress the immune system) — specifically basiliximab, mycophenolate mofetil, and corticosteroids.
FDA approves new test to help determine if breast cancer patients are candidates for Herceptin treatment
The U.S. Food and Drug Administration today approved a new genetic test that will help health care professionals determine if women with breast cancer are HER2-positive and, therefore, candidates for Herceptin (trastuzumab), a commonly used breast cancer treatment.
FDA approves first ceramic-on-metal total hip replacement system
The U.S. Food and Drug Administration approved on June 13 the first ceramic-on-metal total artificial hip system for patients with osteoarthritis.
FDA Announces Changes to Better Inform Consumers About Sunscreen
New Rules Give Consumers More Information to Help Reduce the Risk of Skin Cancer, Early Aging