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National Expert Coleman Reviews Turbo EIR Citations

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FDA national expert Robert Coleman provides an industry conference an overview of the top drug, biologic and device inspectional f...

FDA Extends Review of Wyeth Depression Drug

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FDA extends to 1/22/07 the review date for Wyeths desvenlafaxine succinate extended release for treating major depressive disorder...

FDA Clears Atrium Medical Patch

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FDA clears Atrium Medicals 510(k) to market the iVena Vascular patch for surgical repair and closure of the vascular system.

Advisors Back 2 Radiesse PMAs

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FDAs General and Plastic Surgery Devices Panel recommends approval of two Radiesse PMAs with conditions and reclassification of cy...

Osteoporosis Market Wont Grow, Report Says

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Decision Resources analyst Ramya Kollipara says the U.S. osteoporosis market will plateau in 2015 from the entry of generic Fosama...

Group Wants Fluoroquinolone Black Box Warning

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Public Citizen and the Illinois attorney general ask FDA to order a black box warning and mandatory medication guides for fluoroqu...

Pediatric Exclusivity OKd for Salix Colazal

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FDA accepts Salix pediatric clinical information for Colazal and extends marketing exclusivity for six months.

FDA Evaluating Emergency Research Experience

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FDA announces a public hearing and other steps to evaluate its 10 years of experience with a regulation permitting emergency clini...

Dental Product Facility Warned

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FDAs Seattle District Office warns Pascal Company of CGMP violations affecting its Rx and OTC dental drug products.

FDA Revising Drug Post-approval Change Regulation

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CDER considers revising its post-approval change reporting regulations (21 CFR 314.70) to accommodate more regulatory flexibility ...