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FDA Reclassifies/Renames Female Condom

[ Price : $8.95]

Federal Register notice: FDA proposes to reclassify single-use female condoms, renaming the device to single-use internal condom, ...

Guide on IDE Categorization for CMS Coverage Decisions

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FDA issues a guidance on FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare a...

Pharmaceutical Site Visit Program Seeks Proposals

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Federal Register notice: CDER announces its intent to accept proposals from pharmaceutical companies interested in participating i...

Gottlieb to Meet with Lawmakers on Essure Concerns

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FDA commissioner Scott Gottlieb agrees to meet with Rep. Rosa DeLauro (D-CT) and other members of Congress to discuss the safety o...

Amgen sBLA Approved for Cardiovascular Risk Reduction

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FDA approves an Amgen supplemental BLA for Repatha (evolocumab) for preventing heart attacks, strokes and coronary revascularizati...

FDA Approves Lillys Taltz for Psoriatic Arthritis

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FDA approves Eli Lillys Taltz (ixekizumab) injection 80 mg/mL for treating adults with active psoriatic arthritis.

FDA Accepts Lannett NDA for Topical Anesthetic

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FDA accepts for review a Lannett 505(b)(2) NDA for Numbrino (cocaine hydrochloride) topical solution, 4% and 10%, indicated for us...

68 ANDA Approvals Withdrawn: FDA

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Federal Register notice: FDA announces the withdrawal of 68 ANDAs from multiple applicants.

FDA Approves Cancer Biomarker Test

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FDA approves Foundation Medicines F1CDx next generation sequencing cancer biomarker test.

FDA Approves Mylans Herceptin Biosimilar

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FDA approves Mylans Ogivri (trastuzumab-dkst), the first biosimilar to Genentechs Herceptin, indicated for treating patients with ...