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New OGD Procedure for Grouped CMC Supplements

[ Price : $8.95]

CDER releases a new policy procedure for handling reviews of grouped chemistry, manufacturing and controls supplements.

FDA Rejects Petition Seeking Lindane Ban

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FDA rejects a petition submitted by Natural Resources Defense Council that sought the market withdrawal of products containing lin...

FDA Accepts MAP Pharma Resubmission for Migraine Drug

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FDA accepts for review a MAP Pharmaceuticals NDA resubmission for Levadex (dihydroergotamine) inhalation aerosol for treating migr...

Guidance on Artificial Pancreas Device Systems

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Federal Register Notice: FDA releases a guidance, The Content of Investigational Device Exemption (IDE) and Premarket Approval (PM...

FDA Orphan Status for OxiGene Leukemia Candidate

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FDA grants OxiGene an orphan drug designation for OXi4503 for treating acute myelogenous leukemia.

Alaunus Pharmaceuticals Inspection Results Released

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FDA releases the FDA-483 from a New England District Office 2012 inspection at Alaunus Pharmaceuticals, associated with New Englan...

Hearing to Discuss Preoperative Skin Product Contamination

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Federal Register Notice: FDA plans a pubic hearing 12/12-13 to discuss microbial contamination of patient preoperative skin prepar...

Patanase Sales Aid Overstates Efficacy: OPDP

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CDERs Office of Prescription Drug Promotion notifies Alcon that a professional sales aid for its Patanase overstates the drugs eff...

Findings from 2 St. Jude Medical Inspections Released

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FDA releases the FDA-483 reports from inspections at St. Jude Medical facilities in Puerto Rico and California.

FDA Significant Delay in Warning NECC

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Reuters reports that it took FDA 684 days to issue a Warning Letter after it has inspected the troubled New England Compounding Ce...