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Priority Review for Tagrisso sNDA in Lung Cancer

[ Price : $8.95]

FDA accepts for priority review an AstraZeneca supplemental NDA for Tagrisso (osimertinib) in combination with chemotherapy for tr...

SentiAR 3D Holographic Headset Cleared

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FDA clears a SentiAR 510(k) for its CommandEP, which the company says integrates existing 3D cardiac mapping systems to create a r...

Device Inspection Compliance Program Revised

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FDA updates its (XXX DELETE EXTRA SPACE XXX)Compliance Program Guidance Manual for the Inspection of Medical Device Manufacturers,...

Hogan Lovells Skeptical of New Generics Pilot

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A new CDER Office of Generic Drugs pilot program to offer meeting opportunities to ANDA applicants who intend to use model-integra...

FDA OKs Pfizer Ulcerative Colitis Drug

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FDA approves a Pfizer NDA for Velsipity (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate receptor modulator for...

Topical Ophthalmic Quality Guidance

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Federal Register notice: FDA releases a draft guidance entitled Quality Considerations for Topical Ophthalmic Drug Products.

Info Collection on Recall Regulations

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Federal Register notice: FDA seeks comments on an information collection extension entitled FDA Recall Regulations 21 CFR Part 7....

Canadian Drug Importation: Information Collection

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Federal Register notice: FDA sends to OMB an information collection extension entitled Importation of Prescription Drugs from Cana...

InfoBionic Next-Gen Cardiac Monitor

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FDA clears an InfoBionic 510(k) for its MoMe ARC, the companys third-generation remote electrocardiogram monitoring device.

Heidelberg Engineering Ocular Platform Cleared

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FDA clears a Heidelberg Engineering 510(k) for its ANTERION platform, which the company says is designed to transform anterior seg...