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Bayer Animal Health Challenges Norbrook on its Euroflox

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Bayer Animal Health tells FDA that Norbrook Laboratories is unable to provide a factual finding that users of its Euroflox would f...

FDA Denies Treanda Petition

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FDA denies a Center for Medicine in the Public Interest petition seeking requirements to be placed on applicants for a sNDA for a ...

CDC Backs FDA Efforts on Antibiotics

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The Centers for Disease Control says it backs FDAs strategy for minimizing inappropriate use of antibiotics in humans and animals....

Inadequate Lab Controls Top API Inspection Citation: FDA

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CDER branch chief Alicia M. Mozzachio says inadequate lab controls leads FDAs list of common violations seen at international acti...

Guidance on Labeling Patient Counseling Section

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FDA issues a draft guidance to help applicants develop the Patient Counseling Information section in drug labeling.

FDA Posts August NADA, ANADA Approvals

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Federal Register Final rule: FDA amends the animal drug regulations to reflect August approvals.

Panel to Discuss Janssen NDA for Hepatitis C

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Federal Register Notice: FDAs Antiviral Drugs Advisory Committee will meet 10/24 to discuss a Janssen NDA for simeprevir to treat ...

FDA Warns Against Weight Loss Product

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FDA advises consumers to refrain from purchasing and throw away any bottles of the weight loss product Shou Fu Ti Tun Guo Xiang Xi...

Electronic Source Data Guidance

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FDA publishes a guidance with recommendations for capturing, reviewing, and retaining electronic source data in clinical investiga...

Info on Patents Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on patent submission and listing requirements to the Off...