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Federal court orders rice noodle company to stop selling products until it complies with food safety regulations

On April 27, 2016, the United States District Court for the Northern District of California entered a consent decree of permanent injunction against Kun Wo Food Products Inc., located in San Francisco,... read more

FDA launches public education campaign to prevent and reduce tobacco use among LGBT young adults

The U.S. Food and Drug Administration today announced the launch of a historic public education campaign aimed at preventing and reducing tobacco use among lesbian, gay, bisexual and transgender (... read more

Federal judge enters order of permanent injunction against Paul W. Franck

The U.S. Food and Drug Administration today announced that U.S. District Judge Carlos E. Mendoza entered an order of permanent injunction against Paul W. Franck of Ocala, Florida.... read more

FDA approves first drug to treat hallucinations and delusions associated with Parkinson?s disease

The U.S. Food and Drug Administration today approved Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson?... read more

Food and Drug Adminstration (FDA): CDRHNew

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140017 added)

Mammography Facility Adverse Event and Action Report - May 3, 2016: Giao Van Le MD Inc.

On August 11, 2015, the America College of Radiology (ACR) denied the facility’s request for renewal of accreditation based on deficiencies with the clinical images that were submitted during the accreditation... read more

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140022 added)

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140022 added)

Federal Register: Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices; Public Workshop; Reopening of Comment Period

The FDA is reopening the comment period for the notice of a public workshop that appeared in the Federal Register of March 9, 2016. In the notice of the public workshop, FDA... read more

What's New: Vaccines, Blood & Biologics RSS Feed

HAVRIX

Package Insert Updated December 2009 to include additional adverse events.

INFANRIX

ENGERIX-B

TWINRIX

Active immunization of persons 18 years of age or older against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus

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