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Boxed Warning Added to BIV Cat Drug

[ Price : $8.95]

CVM adds a boxed label warning to Boehringer Ingelheim Vetmedicas Metacam based on reports of many kidney failures and deaths in c...

Bayer Settles With States Over 'Drug' Claims with Vitamins

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Bayer Healthcare agrees to pay $3.3 million to settle charges brought by several states over alleged misleading claims it made on ...

CDRH Scraps Flowchart in 510(k) Changes Guidance Revision

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CDRH Office of Device Evaluation acting director Christy Foreman tells an industry conference that a revision the Centers longstan...

Strategic Plan, Goals Needed for Foreign Posts: GAO

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A new GAO report says FDA needs to set performance goals and measures for its new overseas offices and also develop a strategic wo...

DDMAC Warns AMAG Pharma on Web Pages

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A DDMAC Warning Letter to AMAG Pharmaceuticals' cited product promotional material found on the company's Web pages.

Shire Receives Watson Paragraph IV Notice on Intuniv

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Shire receives a Paragraph IV Notice from Watson Laboratories stating that it has filed an ANDA with FDA for a generic version of ...

Class I Recall of Excelsior Syringes

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Excelsior Medical Corp. has initiated a Class 1 recall of its disposable syringe with normal saline (0.9% sodium chloride, 5mL fil...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Amag Pharmaceuticals, Axis Health, Impact Instrumentation, Howard Lippton, Natur...

GAO Finds 'Urgent' Need for More FDA Foreign Inspections

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A new GAO report says the need for more FDA foreign inspections has now become urgent if the nation's drug supply is to be safe.

White Paper on FDA Review Trends

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A new Parexel white paper on FDA review trends finds increasing new molecular entity (NME) submissions last year, and a softening ...