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Info On CLIA Requests Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on requests for Clinical Laboratory Improvement Amendmen...

Panel to Discuss Gilead Sciences NDA for Hepatitis C

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Federal Register Notice: FDAs Antiviral Drugs Advisory Committee will meet 10/25 to discuss a Gilead Sciences NDA for treating chr...

FDA Clears Lumenis Skin Resurfacing Laser Module

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FDA grants 510(k) clearance to Lumenis Ltd. for the ResurFX, a fractional non-ablative laser module for skin resurfacing.

Woodcock to Personally Oversee Latest Drug Quality Push

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CDER director Janet Woodcock says FDAs latest push to advance pharmaceutical quality will be directed by her personally as part of...

Info on Electronic Labeling for Drugs, Biologics Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on labeling for prescription drugs and biologics in elec...

Workshop on Devices to Treat Metabolic Diseases

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Federal Register Notice: FDA plans a public workshop 10/17 on changing regulatory and reimbursement paradigms for medical devices ...

FDA Complete Response Letter on Delcath NDA

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FDA issues Delcath Systems a complete response letter for an NDA for its Melblez Kit (melphalan) for injection for use with the De...

Ge Pharma Recalls Stimulant-containing Creafuse

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Ge Pharma recalls Creafuse Powder Grape (Lot# GE4568) and Creafuse Powder Fruit Punch (Lot #GE4570) because they contain an undecl...

CDER Adds Lexiscan to Safety Watch List

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CDER says it has identified a potential safety issue with Astellas Lexiscan (regadenoson) an increased risk of myocardial infarct...

Millennium Seeks Higher Approval Bar on Fresenius Velcade Copy

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Millennium Pharmaceuticals petitions FDA seeking additional pre-approval requirements on a Fresenius 505(b)(2) NDA for bortezomib ...