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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
Clears Test that Helps Identify Type of Cancer in Tumor Sample
The U.S. Food and Drug Administration has cleared for marketing a test
that can help health care professionals determine what type of cancer
cells are present in a malignant tumor. The Pathwork Tissue of Origin
test compares the genetic material of a patient's tumor with genetic information
on malignant tumor types stored in a database. [ Read
more ]
FDA
Extends Consumer Warning on Serrano Peppers from Mexico
Laboratory testing by the U.S. Food and Drug Administration has confirmed
that both a sample of serrano pepper and a sample of irrigation water
collected by agency investigators on a farm in the state of Nuevo Leon,
Mexico, contain Salmonella Saintpaul with the same genetic fingerprint
as the strain of bacteria that is causing the current outbreak in the
United States. [ Read
more ]
Federal
Agents Seize more than $24 Million in Unapproved New Drugs
Representatives of the U.S. Food and Drug Administration and the U.S.
Marshals Service today seized $24.2 million worth of unapproved new drugs
from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United
States Attorney Catherine L. Hanaway filed a civil forfeiture suit and
obtained a warrant to seize the unapproved new drug products being made
by KV Pharmaceutical. [ Read
more ]
FDA
Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches
and Bipolar Disorder
The U.S. Food and Drug Administration today approved the first generic
version of Depakote delayed-release tablets (divalproex sodium). Depakote
is approved by the FDA for the treatment of seizures, bipolar disorder
and migraine headaches. [ Read
more ]
FDA
Advises Against Consumption of American Lobster (Maine Lobster) Tomalley
The U.S. Food and Drug Administration today warned consumers to avoid
eating tomalley in American Lobster (Maine Lobster), regardless of where
the lobster was harvested, because of potential contamination with dangerous
levels of the toxins that cause Paralytic Shellfish Poisoning (PSP). [
Read
more ]
U.S.
Grown Jalapeño and Serrano Peppers Not Connected to Salmonella
Saintpaul Outbreak
The U.S. Food and Drug Administration is advising consumers that jalapeño
and serrano peppers grown in the United States are not connected with
the current Salmonella Saintpaul outbreak. However, the FDA continues
to advise consumers to avoid raw jalapeño peppers--and the food
that contains them--if they have been grown, harvested or packed in Mexico.
[ Read
more ]
Federal
Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall
Product
At the request of the U.S. Food and Drug Administration, U.S. Marshals
seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI,
distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed
as a dietary supplement to treat erectile dysfunction (ED) and for sexual
enhancement, these lots represent an illegally marketed drug containing
an undeclared ingredient. [ Read
more ]
FDA
Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals
The U.S. Food and Drug Administration (FDA) today announced it is launching
a two-year fellowship program aimed at attracting scientists, engineers
and health professionals to the agency. [ Read
more ]
FDA
Reaches Settlement with California Hearing Device Maker
The U.S. Food and Drug Administration (FDA) has reached a settlement with
California hearing device manufacturer Advanced Bionics LLC and its president
and CEO Jeffrey Greiner over alleged violations of federal law. [ Read
more ]
FDA
Revises Process for Responding to Drug Applications
The U.S. Food and Drug Administration announced that it is revising the
way it communicates to drug companies when a marketing application cannot
be approved as submitted. [ Read
more ]
FDA
Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs
The U.S. Food and Drug Administration (FDA) has notified manufacturers
of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product
labeling concerning the increased risk of tendinitis and tendon rupture
is necessary. [ Read
more ]
FDA
Approves New Genetic Test for Patients with Breast Cancer
The U.S. Food and Drug Administration has approved a novel genetic test
for determining whether patients with breast cancer are good candidates
for treatment with the drug Herceptin (trastuzumab). [ Read
more ]
FDA
Food Protection Plan Shows Significant Progress
The U.S. Food and Drug Administration's Food Protection Plan Progress
Report, released today in conjunction with the Interagency Working Group
on Import Safety Action Plan Update, shows significant areas of activity
to further improve the safety of America's food supply since unveiling
its Food Protection Plan in November 2007. [ Read
more ]
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