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Medtronic Plans Trial for Drug Therapy with Stent

[ Price : $8.95]

Medtronic says it will conduct a randomized clinical trial to evaluate one-month dual antiplatelet therapy the combination of asp...

Comments Sought Scheduling Impact on 17 Drugs

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Federal Register notice: FDA requests comments about abuse potential, actual abuse, medical usefulness, trafficking, and impact of...

Lipocine NDA Resubmission for Testosterone Product

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Lipocine resubmits an NDA for Tlando, an oral testosterone product candidate for testosterone replacement therapy in adult males f...

International Labs Recalls Mislabeled Pravastatin

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International Laboratories recalls one lot of pravastatin sodium tablets USP 40 mg packaged in bottles of 30 tablets due to mislab...

Latest Federal Register Notices

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FDA Review posts the latest Federal Register notices for the week ending 8/11/2017.

FDA, Chiasma Reach Agreement on SPA

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FDA and Chiasma reach agreement on a special protocol assessment on the design of a new Phase 3 clinical trial for its octreotide ...

Priority Review for Gilead NDA for HIV Combo Therapy

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FDA grants Gilead Sciences a priority review for its NDA for an investigational, fixed-dose combination of bictegravir (50mg) and ...

Trump Declares Opioid Crisis a National Emergency

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President Donald Trump says he is declaring the opioid epidemic a national emergency.

FDA Clears Renovis Surgical Fusion System

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FDA clears a Renovis Surgical Technologies 510(k) to market posterior lumbar Tesera porous titanium interbody fusion systems.

Orphan Status for Antheras Blisibimod

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FDA grants Anthera Pharmaceuticals an orphan drug designation for blisibimod for treating immunoglobulin A nephropathy.