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Comments Sought on Conditional Approval of New Animal Drugs

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Federal Register Notice: FDA invites comments on the use of conditional approval beyond new animal drugs for minor species/minor u...

Comments Sought on Combo Medicated Feed Requirements

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Federal Register Notice: FDA seeks comments on modifying the current requirement that multiple new animal drugs in a combination m...

FDA Corrects Notice on Advisory Panel Renewal

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Federal Register Notice: FDA corrects several errors in an 8/25 notice that renewed several advisory committee charters.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites CreAgri and MicroTest.

FDA Guide on Dengue Virus Test Reagent Controls

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FDA releases Class 2 Special Controls Guideline: Dengue Virus Nucleic Acid Amplification Test Reagents that applies to reagents th...

FTC Says Companies Blocked Generic AndroGel

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The Federal Trade Commission says AbbVie, Besins, and Teva illegally blocked consumer access to lower-cost versions of branded And...

Stakeholders Support Parts of MDDS Guidance

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Stakeholders voice some effort for the FDA enforcement discretion approach in a draft guidance on medical device data systems and ...

Teva Defends its Copaxone Petition

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Teva calls on FDA to post all data and other information from any company commenting on its petition seeking restrictions on Copax...

Focusing Drug Trial Protocols is Working: Tufts

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A Tufts Center for the Study of Drug Development Impact Report says that drug company efforts to focus clinical trial protocols to...

CDRH Director Shuren Dismisses Hill Calls for LDT Rulemaking

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CDRH director Jeff Shuren says FDA is not obligated to follow the Administrative Procedures Act and undergo formal rulemaking on i...