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FDA
Recalls
FDA posts press releases and other notices of recalls and market withdrawals
from the firms involved as a service to consumers, the media, and other
interested parties. FDA does not endorse either the product or the company.
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Recent news from the US Food and Drug Administration.
Click "read more" links to see the full article at the FDA
website. For the most up-to-date headlines, check out the FDA
Newsroom.
FDA
Warns Consumers Against Dietary Supplement Containing Undeclared Drug
- January 27, 2009
The U.S. Food and Drug Administration is warning consumers not to take
Venom HYPERDRIVE 3.0, a product sold as a dietary supplement and containing
sibutramine. Sibutramine, a controlled substance with risks for abuse
or addiction, is a potent drug that poses potential safety risks. [ Read
more ]
FDA
Updates Information on Salmonella Typhimurium Investigation
- January 19, 2009
The U.S. Food and Drug Administration has updated its information on its
Web site regarding the investigation into the Salmonella Typhimurium outbreak.
Please visit the FDA Web site for the latest details: http://www.fda.gov/oc/opacom/hottopics/salmonellatyph.html.
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FDA
Approves RiaSTAP for Treatment of Bleeding in Patients with Rare Genetic
Defect - January 16, 2009
The U.S. Food and Drug Administration today licensed RiaSTAP, an orphan
drug for the treatment of bleeding in patients with a rare genetic defect
known as congenital fibrinogen deficiency. Without treatment, these patients
are at risk of potentially life-threatening bleeding. [ Read
more ]
FDA
Alerts Public about Danger of Skin Numbing Products: Serious and life-threatening
risks associated with improper use - January 16, 2009
The U.S. Food and Drug Administration today issued a Public Health Advisory
to alert consumers, patients, health care professionals, and caregivers
about potentially serious and life-threatening side effects from the improper
use of skin numbing products. The products, also known as topical anesthetics,
are available in over-the-counter (OTC) and prescription forms. [ Read
more ]
FDA
Consumer Health Information Update For This Week - January 15,
2009
The U.S. Food and Drug Administration (FDA) today released its biweekly
list of consumer health information updates. All updates appear on the
agency’s Web page for consumers, www.fda.gov/consumer. Visit www.fda.gov/consumer/consumerenews.html
to sign-up for e-mail notices of new updates on an immediate, weekly,
or monthly basis. An RSS feed is available at www.fda.gov/consumer/rssConsumer.xml.
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FDA
Issues Guidances for Industry to Improve the Safety of Food, Feed and
Drugs - January 15, 2009
The U.S. Food and Drug Administration today issued three guidances designed
to help ensure the safety of FDA-regulated products in the supply chain.
The documents issued today include the following: Final Guidance for Industry
on Voluntary Third-Party Certification Programs for Foods and Feeds; Draft
Guidance for Industry on Submission of Laboratory Packages by Accredited
Laboratories; and Draft Guidance for Industry on Standards for Securing
the Drug Supply Chain – Standardized Numerical Identification for
Prescription Drug Packages. [ Read
more ]
FDA
Issues Final Guidance on Regulating Genetically Engineered Animals
- January 15, 2009
The U.S. Food and Drug Administration today issued a final guidance for
industry on the regulation of genetically engineered (GE) animals under
the new animal drug provisions of the Federal Food, Drug and Cosmetic
Act (FFDCA). The guidance, titled "The Regulation of Genetically
Engineered Animals Containing Heritable rDNA Constructs," clarifies
the FDA's statutory and regulatory authority, and provides recommendations
to producers of GE animals to help them meet their obligations and responsibilities
under the law. [ Read
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FDA
Launches Pilot Program To Improve the Safety of Drugs and Active Drug
Ingredients Produced Outside the United States - January 14, 2009
The U.S. Food and Drug Administration today announced the launch of a
voluntary pilot program that would help promote the safety of drugs and
active drug ingredients produced outside the United States. [ Read
more ]
FDA
Announces Two Appointments - January 12, 2009
Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D., today announced
the appointments of Lou Valdez as associate commissioner for international
programs, and of Lori Davis as chief information officer. [ Read
more ]
Federal
Agencies Issue Draft Guidance for Industry Good Importer Practices
- January 12, 2009
The U. S. Departments of Health and Human Services, Agriculture, Commerce,
Homeland Security, and Transportation and the U.S. Consumer Product Safety
Commission, the U.S. Environmental Protection Agency, and the Office of
the U.S. Trade Representative today issued draft guidance for industry
titled “Good Importer Practices.” The guidance is designed to
provide guidance to importers on steps they can take to help ensure imported
products are in compliance with applicable U.S. statutes and regulations.
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more ]
FDA
Awaits Court's Entry of A Permanent Injunction Against Actavis Totowa,
LLC - January 9, 2009
Today, the U.S. Food and Drug Administration announced that it had filed
a Consent Decree on December 23, 2008, and currently awaits the court's
entry of a permanent injunction that bars Actavis Totowa, LLC, Actavis,
Inc., and their officers, Sigurdur Oli Olafsson and Douglas Boothe, from
manufacturing and distributing drugs at the Actavis Totowa facilities.
The injunction will remain in effect until Actavis Totowa comes into compliance
with U.S. current Good Manufacturing Practice (cGMP) requirements, and
obtains FDA's approval to manufacture and distribute drugs in the United
States. The companies and their officers had also been manufacturing and
distributing unapproved drugs in the United States. [ Read
more ]
FDA
Issues Update to Safety Review on Cholesterol-Lowering Drugs -
January 9, 2009
The U.S. Food and Drug Administration today reaffirmed its position that
elevated amounts of low-density lipoprotein (LDL), or “bad cholesterol,”
are a risk factor for cardiovascular diseases such as heart attack, stroke
and sudden death and that lowering LDL cholesterol reduces the risk of
these diseases. [ Read
more ]
FDA
Prevents Two Dairies from Adulterating Animal Drugs and Food -
January 2, 2009
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. [ Read
more ]
FDA
Announces Class I Recall of Ophthalmic Surgical Device - January
2, 2009
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. OVDs are viscoelastic
materials used to maintain space in the eye during surgery. Typically,
OVDs are pre-packaged in a syringe and are applied using a small tube.
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