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FDA seeks court order against Michigan dairy
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Scenic View Dairy of Hamilton, Mich.,... read more
FDA launches new organizational performance management system
The U.S. Food and Drug Administration today launched an innovative performance management system designed to advance the President?s commitment to transparency, public participation, and collaboration in the work... read more
FDA Warns Consumers to Avoid TimeOut Capsules
The U.S. Food and Drug Administration is warning consumers not to take TimeOut Capsules because it contains an active drug ingredient that can dangerously lower blood pressure. The product... read more
FDA releases guidance on federal menu labeling requirements
The U.S. Food and Drug Administration today released two documents that outline steps to help chain restaurants comply with new federal nutrition labeling requirements.
Food and Drug Adminstration (FDA): CDRHNew
Guidance for Industry and FDA Staff - Impact-Resistant Lenses: Questions and Answers
Eyeglasses and sunglasses (eyewear) that are intended to affect the structure or function of the body or intended for use in the diagnosis of disease or other conditions, or in... read more
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions and Answers; Availability.
The FDA is announcing the availability of the guidance entitled 'Impact-Resistant Lenses: Questions and Answers.' This guidance document answers manufacturer, importer, and consumer questions on impact-resistant lenses, including... read more
Office of Device Evaluation Annual Performance Report Fiscal Year 2009
In the past, the ODE Annual Report included information from and about the ODE Review Divisions, our initiatives, and data analysis from the ODE Program Operations Staff (POS). The FY 09... read more
Federal Register: Medical Device User Fee Act; Public Meeting; Request for Comments; Amendment of Notice
The FDA is announcing an amendment to the notice of a public meeting on the reauthorization of the medical device user fee program. This meeting was announced in the Federal... read more
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August 26, 2010 Approval Letter - Infanrix
a prefilled syringe which has a tip cap which may contain natural rubber latex and plunger which does not contain latex
Infanrix
Jobs at the Center for Biologics Evaluation and Research (CBER)
Interdisciplinary Scientist, Closes: 4/23/2010; Supervisory Contract Specialist (Direct Hire), Closes: 12/31/2010
August 23, 2010 Approval Letter - Havrix
Revised the Package Insert and pre-filled syringe carton to include the appropriate warnings regarding latex containing components.
