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Panel to Discuss Theravance NDA for Pneumonia Treatment

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Federal Register Notice: FDAs Anti-Infective Drugs Advisory Committee will meet 11/29 to discuss a Theravance NDA for Vivativ for ...

FDA OKs Acton Pharma sNDA for Asthma

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FDA approves an Acton Pharmaceuticals sNDA for Aerospan Inhalation indicated for the maintenance treatment of asthma as a prophyla...

FDA Clears Intelomed 510(k) for CVInsight

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FDA clears an Intelomed, Inc. 510(k) for its CVInsight device that measures and displays a patients vital signs and cardiovascular...

Eutropics to Develop Multiple Myeloma Diagnostic

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The National Cancer Institute contracts with Eutropics Pharmaceuticals for a Phase 2 commercial development of a diagnostic assay ...

Increased Inspections Biggest User Fee Win: FDA

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FDA senior policy advisor and chief negotiator Peter Beckerman tells a user fee conference that increased resources for regular su...

FDA Preliminary Warning on Mirapex Heart Risk

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FDA warns healthcare professionals about a possible increased risk of heart failure with Boehringer Ingelheim Pharmaceuticals Mira...

Public Citizen Asks End to Minor Deletions in FOIA Responses

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Public Citizen calls on FDA to end its policy of redacting portions of documents given to Freedom of Information Act requesters wi...

Dont Take Ear Candlers Warning Letter Case: FDA

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FDA asks the Supreme Court not to hear a case brought by five ear candle manufacturers who claim that agency Warning Letters are f...

FDA Backs Class 2 for Spinal Screw Systems

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FDA says it agrees with the Orthopedic Special Manufacturers Association that posterior cervical screws should be Class 2.

FDA Panel to Discuss Celgene NDA for Multiple Myeloma

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FDAs Oncologic Drugs Advisory Committee will meet 11/8 to discuss a Celgene Corp. NDA for pomalidomide for use in combination with...