FDA staff questions Sanofi bird flu vaccine
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Data on Sanofi-Aventis's   experimental bird flu vaccine shows higher doses worked better, but it is unclear whether those results prove the product's effectiveness, U.S. regulatory staff said in documents released on Monday.
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The U.S. Food and Drug Administration is facing new questions about its ability to police the safety of medicines after they reach the market following concerns about a widely used diabetes drug.
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A panel of experts will meet on Tuesday to consider whether the Food and Drug Administration should approve Sanofi-Aventis' experimental bird flu vaccine, which could become the first such product cleared for the U.S. market.
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US health officials Monday denied reports that they knew before last week that there were major production problems with a key American manufacturer&#39;s flu vaccine, which
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Data on Sanofi-Aventis's    experimental bird flu vaccine shows higher doses  worked better, but it is unclear whether those results prove  the product's effectiveness, U.S. regulatory staff said in  documents released on Monday.
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The Food and Drug Administration is unlikely to clear influenza vaccine made by Chiron Corp. as safe for Americans to use this flu season, Dr.
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By ANDREW BRIDGES WASHINGTON - A bird flu vaccine that's even less effective than previously thought could still play an important role in protecting against the increased likelihood of a pandemic, a government health official said Tuesday.
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WASHINGTON -- Flu vaccine manufacturer Chiron has three weeks to respond to a Food and Drug Administration warning letter that alleges violations of FDA regulations at the company&#39;s plant in Liverpool, England, where contamination problems led to the US
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WASHINGTON - The Food and Drug Administration is unlikely to clear influenza vaccine made by Chiron Corp. as safe for Americans to use this flu season, Dr...
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An internal survey of Food and Drug Administration scientists conducted by the Health and Human Services Office of the Inspector General revealed safety concerns about the FDAâs approval process and monitoring of marketed drugs, according to a press
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US Food and Drug Administration staff reviewers on Tuesday questioned clinical data for non-Hodgkin&#39;s lymphoma drug Marqibo, made by Inex Pharmaceuticals Corp.
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A Food and Drug Administration advisory panel unanimously agreed yesterday that MedImmune's nasal flu vaccine FluMist worked in children under age 5, but it had a decidedly mixed opinion on whether the product was safe enough for children younger than 2.
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An FDA review of AstraZeneca Plc&#39;s (AZN.L: Quote, Profile, Research) (AZN.N: Quote, Profile, Research) Exanta questioned the experimental drug&#39;s
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A leading doctor is questioning the government's approach over offering routine flu jabs for children under two.
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The decision by British authorities to suspend the license of a major influenza vaccine manufacturer just before the vaccine was to be shipped shows a need for better communication, acting FDA chief Dr. Lester Crawford said on Monday.
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The federal Food and Drug Administration&#39;s ability to protect the American public is in question in the wake of the problems with this year&#39;s flu vaccine shortage and claims that it is allowing unsafe drugs to remain on the market.
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Emeryville-based Chiron Corp. (CHIR) has asked British regulators to inspect its facility producing an experimental bird flu vaccine to make sure it doesn't run into the same contamination problems that forced ...