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Guide on Consensus Standards Recognition/Withdrawal

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Recognition and Withdrawal of Voluntary Consensus Standards...

Draft Guide on 510(k) Third-Party Review Program

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled 510(k) Third-Party Review Program.

Biotronik Device for Coronary Artery Perforations OKd

[ Price : $8.95]

FDA approves a Biotronik humanitarian device exemption for its PK Papyrus Covered Coronary Stent System which is intended to treat...

Sun Pharma Glaucoma Drug Approved

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FDA approves a Sun Pharmaceutical Industries NDA for Xelpros (latanoprost ophthalmic emulsion) 0.005% for reducing elevated intrao...

FDA Posts ANDA Bioequivalence Study Guides

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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that recommend bioequiv...

PMRS Sues FDA Over Hearing on Rejected NDA

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Pharmaceutical Manufacturing Research Services files (XXX SPACE XXX)a lawsuit against FDA in eastern PA federal court seeking an o...

Guide on Voluntary Consensus Standards

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Federal Register notice: FDA makes available a final guidance entitled Appropriate Use of Voluntary Consensus Standards in Premark...

Safety Alert on Alcons CyPass Micro-Stent

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FDA issues a safety alert on Alcons CyPass Micro-Stent, a small tube with tiny holes that is surgically implanted in the eye, due ...

Streamlining Third-Party Device Reviews

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FDA announces steps to streamline its use of medical device third party reviewers.

AstraZenecas Lumoxiti for Hairy Cell Leukemia

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FDA approves AstraZeneca Pharmaceuticals Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for treating adult pa...