What's New at CBER Update

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Agriflu
Approval History, Letters, Reviews, and Related Documents, Updated: 12/24/2009

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Mountain Man Nut & Fruit Co.® Announces Voluntary Recall of Hazelnut

Mountain Man Nut & Fruit Co.® Announces Voluntary Recall of Hazelnut
Wed, 23 Dec 2009 23:22:00 -0600

Mountain Man Nut & Fruit Co. is voluntarily recalling select products containing shelled hazelnuts (filberts). Mountain Man is initiating this recall in conjunction with the recall from Kunze Fams due to the fact that raw hazelnuts could have been exposed to salmonella and become contaminated. During routine inspection of the hazelnut shelling facility one salmonella test came back positive. In the interest of the safety of our customers, Mountain Man is requesting that customers return any of the lot codes below to their place of purchase for replacement or refund.

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Market of Choice Recalls Hazelnuts Because of Possible Health Risks

Market of Choice Recalls Hazelnuts Because of Possible Health Risks
Wed, 23 Dec 2009 15:33:00 -0600

Market of Choice is recalling bulk and packaged hazelnuts (filberts) that were processed at Willamette Shelling Inc. for Evonuk Oregon Hazelnuts. The nuts were recalled from seven Market of Choice stores in Oregon on December 17.

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FDA Approves A High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older

FDA Approves A High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older
Thu, 24 Dec 2009 06:27:00 -0600

The U.S. Food and Drug Administration today approved Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B.

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What's New at CBER Update

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Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release 
Lot release information, Updated: 12/24/2009

Influenza Virus Vaccine for the 2009-2010 Season 
Lot release information, Updated: 12/24/2009

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What's New at CBER Update

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Fluzone High-Dose
Posted: 12/23/2009

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FDA: Orphan Drug Workshops Scheduled For Feb. 25-26 and Aug. 3-4, 2010

FDA: Orphan Drug Workshops Scheduled For Feb. 25-26 and Aug. 3-4, 2010
Wed, 23 Dec 2009 10:00:00 -0600

As part of its continuing effort to make the agency more transparent and accessible, the FDA has scheduled a series of workshops about orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process. The FDA can grant a special status, known as orphan designation, for drug products intended to treat rare diseases.

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