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Press releases from FDA
Updated: 3 days 10 hours ago

FDA Prevents Two Dairies from Adulterating Animal Drugs and Food

Fri, 2009-01-02 14:22
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.
Categories: FDA

FDA Announces Class I Recall of Ophthalmic Surgical Device

Fri, 2009-01-02 14:22
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.
Categories: FDA

FDA Approves First Nucleic Acid Test to Screen for Additional Types of HIV in Donated Blood and Tissue

Tue, 2008-12-30 22:51
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.
Categories: FDA

FDA Approves Drug for Patients with Advanced Prostate Cancer

Mon, 2008-12-29 15:32
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.
Categories: FDA

FDA Approves First Imaging Agent to Enhance Scans of Blood Flow

Wed, 2008-12-24 17:25
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.
Categories: FDA

Historic Building One Dedicated at FDA's White Oak Federal Research Center

Thu, 2008-12-18 22:42
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.
Categories: FDA

FDA Approves Drug that Boosts Stem Cell Yield for Bone Marrow Transplants

Thu, 2008-12-18 20:18
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.
Categories: FDA

FDA Announces New Recommendations on Evaluating Cardiovascular Risk in Drugs Intended to Treat Type 2 Diabetes

Wed, 2008-12-17 18:56
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.
Categories: FDA

FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications

Tue, 2008-12-16 21:17
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).
Categories: FDA

Study Finds Much of Private-Sector Consumer Medication Information Not Consistently Useful

Tue, 2008-12-16 17:23
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.
Categories: FDA

FDA Announces Class I Recalls of Two Unapproved Devices

Mon, 2008-12-15 20:11
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.
Categories: FDA

FDA Warns Consumers and Retailers of Botulism Risk from Ungutted, Salt-Cured Alewives (Gaspereaux) Fish

Fri, 2008-12-12 21:39
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.
Categories: FDA

FDA Requires New Safety Measures for Oral Sodium Phosphate Products to Reduce Risk of Acute Kidney Injury

Thu, 2008-12-11 19:32
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.
Categories: FDA

FDA Education Program Wins Award

Tue, 2008-12-09 21:31
'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.
Categories: FDA

FDA Announces Permanent Injunction Against Wilderness Family Naturals LLC

Tue, 2008-12-09 20:50
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.
Categories: FDA

FDA, EPA and USDA Conclude That Accidental Release of Genetically Engineered Cotton Poses No Safety Risk to Humans or Animals

Wed, 2008-12-03 22:13
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.
Categories: FDA

FDA Announces Participants of Pilot Program for Third-Party Certification of Imported Aquacultured Shrimp

Wed, 2008-12-03 17:30
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.
Categories: FDA

FDA Teams With WebMD For New Online Consumer Health Information

Wed, 2008-12-03 12:50
The U.S. Food and Drug Administration and WebMD today announced a collaboration that expands consumers' access to the agency's timely and reliable important health information. This joint effort reflects the FDA's emphasis on using innovative, technology-based strategies to carry out its foremost mission, which is to promote and to protect the public health.
Categories: FDA

FDA Reports Significant Progress in Protecting the Food Supply

Mon, 2008-12-01 13:14
The U.S. Food and Drug Administration today released a report on its implementation of the Food Protection Plan that was launched a year ago to protect both domestic and imported food from accidental and intentional contamination. The Plan, which outlines strategies for prevention, intervention and response, is designed to address food safety and food defense for both domestic and imported products and covers the full lifecycle of food, by encouraging the building of safety into every step of the food supply chain.
Categories: FDA

FDA Approves New Drug to Alleviate Moderate to Severe Pain

Mon, 2008-11-24 17:30
The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain.
Categories: FDA


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