Latest FDA News
FDA Prevents Two Dairies from Adulterating Animal Drugs and Food
The U.S. Food and Drug Administration announced today that the District Court for the District of New Mexico has enjoined Do-Rene and Clover Knolls Dairies and their owners, Douglas B. Handley and Irene Handley, from adulterating new animal drugs and introducing adulterated food into commerce. Both companies are based in Clovis, N.M.…
FDA Announces Class I Recall of Ophthalmic Surgical Device
The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif.…
FDA Approves First Nucleic Acid Test to Screen for Additional Types of HIV in Donated Blood and Tissue
The U.S. Food and Drug Administration today approved the cobas TaqScreen MPX Test, the first nucleic acid test that screens for the presence of two divergent types of HIV in donated blood plasma and tissue.…
FDA Approves Drug for Patients with Advanced Prostate Cancer
The U.S. Food and Drug Administration recently approved the injectable drug degarelix, the first new drug in several years for prostate cancer. Degarelix is intended to treat patients with advanced prostate cancer. It belongs to a class of agents called gonadotropin releasing hormone (GnRH) receptor inhibitors. These agents slow the growth and progression of prostate cancer by suppressing testosterone, which plays an important role in the continued growth of prostate cancer.…
FDA Approves First Imaging Agent to Enhance Scans of Blood Flow
The U.S. Food and Drug Administration today approved Vasovist Injection (gadofosveset trisodium), the first contrast imaging agent for use in patients undergoing magnetic resonance angiography, or MRA, a minimally invasive test for examining blood vessels.…
FDA Warns Consumers About Tainted Weight Loss Pills
The U.S. Food and Drug Administration is alerting consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk.…
FDA Obtains Injunction to Stop Production of Illegally Medicated Animal Feed
The U.S. Food and Drug Administration announced today that the District Court for the Western District of Missouri entered a Consent Decree on Dec. 15, 2008, prohibiting Milbank Mills, an animal feed mill in Chillicothe, Mo., from manufacturing, processing, or distributing medicated animal feed. Milbank Mills and its officers Edward P. Milbank and Darrell L. Allen, face these restrictions until they comply with current Good Manufacturing Practice (cGMP) requirements for medicated animal feeds.…
FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer
The U.S. Food and Drug Administration today approved Gleevec (imatinib mesylate) for a new indication keeping cancer from growing in patients following surgical removal of a gastrointestinal stromal tumor or GIST.…
Historic Building One Dedicated at FDA's White Oak Federal Research Center
The General Services Administration's National Capital Region (GSA/NCR), the U.S. Department of Health and Human Services (HHS), and the HHS Food and Drug Administration (FDA) today dedicated historic Building One at the White Oak Federal Research Center in Silver Spring, Md.…
FDA Approves Drug that Boosts Stem Cell Yield for Bone Marrow Transplants
The U.S. Food and Drug Administration today approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer.…
FDA Announces New Recommendations on Evaluating Cardiovascular Risk in Drugs Intended to Treat Type 2 Diabetes
The U.S. Food and Drug Administration recommended today that manufacturers developing new drugs and biologics for type 2 diabetes provide evidence that the therapy will not increase the risk of such cardiovascular events as a heart attack. The recommendation is part of a new guidance for industry that applies to all diabetes drugs currently under development.…
FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications
The U.S. Food and Drug Administration today announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality).…
Study Finds Much of Private-Sector Consumer Medication Information Not Consistently Useful
A study released today by the U.S. Food and Drug Administration found that the printed consumer medication information (CMI) voluntarily provided with new prescriptions by retail pharmacies does not consistently provide easy-to-read, understandable information about the use and risks of medications.…
FDA Announces Class I Recalls of Two Unapproved Devices
The U.S. Food and Drug Administration (FDA) announced a Class 1 recall today for two unapproved and uncleared devices whose manufacturers claimed could treat various medical conditions. A Class 1 recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death.…
FDA Warns Consumers and Retailers of Botulism Risk from Ungutted, Salt-Cured Alewives (Gaspereaux) Fish
The U.S. Food and Drug Administration is warning retailers and food service operators not to offer for sale ungutted, salt-cured alewives (also called gaspereaux fish) from Michel and Charles LeBlanc Fisheries Ltd., CAP-PELE, New Brunswick, Canada, because the fish may contain the Clostridium botulinum (C. botulinum) toxin. Consumers should not consume the product.…
FDA Requires New Safety Measures for Oral Sodium Phosphate Products to Reduce Risk of Acute Kidney Injury
Today, the U.S. Food and Drug Administration announced that it will add a Boxed Warning to the prescription oral sodium phosphate products Visicol and OsmoPrep to warn consumers about the risk of acute phosphate nephropathy (a type of acute kidney injury). Patients routinely take OSP products to cleanse the bowel before a colonoscopy (colon examination) and other medical procedures.…
FDA Education Program Wins Award
'FDA Patient Safety News,' the FDA's monthly video series for health care professionals, has won the Cheers Award from the Institute for Safe Medication Practices (ISMP) for efforts to improve the safe use of medical products and prevent medical errors.…
FDA Announces Permanent Injunction Against Wilderness Family Naturals LLC
The U.S. Food and Drug Administration today announced that Wilderness Family Naturals LLC of Silver Bay, Minn., and its owners have signed a consent decree that prohibits them from manufacturing and distributing any products with unapproved claims that the products cure, treat, mitigate or prevent diseases.…
FDA, EPA and USDA Conclude That Accidental Release of Genetically Engineered Cotton Poses No Safety Risk to Humans or Animals
The U.S. government announced today that there is no food or feed safety concern from an incident in which a small portion of an unauthorized genetically engineered (GE) cotton variety was harvested along with commercially available GE cotton.…
FDA Announces Participants of Pilot Program for Third-Party Certification of Imported Aquacultured Shrimp
The U.S. Food and Drug Administration today announced the participants in Phase II of its pilot program for voluntary third-party certification programs for imported aquacultured shrimp.…
