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FDA Posts Drug Sampling, Testing Program Details

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FDA describes its process for post-marketing monitoring and testing of finished drugs and active pharmaceutical ingredients to ens...

Government Seeks Injunction Against Laser Maker

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The Justice Department files a civil complaint for injunctive relief in South Dakota federal court against 2035 Inc. for marketing...

Guidance on Galactomannan Detection in Aspergillosis

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Federal Register Notice: FDA makes available: Draft Guidance on Qualification of Biomarker Galactomannan in Studies of Treatments...

FDA Wants More Data from Sarepta on Duchenne Drug

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FDA deals Sarepta Therapeutics another blow by asking for additional data to be included in the companys planned NDA for eteplirse...

FDA OKs St. Jude Medical TactCath Quartz Ablation Catheter

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FDA approves a St. Jude Medical PMA for its TactiCath Quartz irrigated ablation catheter, a real-time objective measure of the for...

Pfizer Walks Away From Remoxy Development

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Pfizer tells its development partner Pain Therapeutics that it has decided to discontinue its agreement to develop and commerciali...

Baxter Recalls 2 Intravia Container Lots

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Baxter International recalls two lots of Intravia containers in the U.S. and Canada due to complaints about particulate matter fou...

Group Challenges FDA on Animal Data Reliance

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The Center for Responsible Science says FDA should refine its recently released Draft Informed Consent Information Sheet: Guidance...

FDA Grants MediciNova Orphan Status for IPF Drug

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FDA grants MediciNova an orphan-drug designation for MN-001 (tipelukast) for treating idiopathic pulmonary fibrosis.

Rich Pharma Submits IND to FDA for Blood Diseases

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Rich Pharmaceuticals submits an IND application to FDA for a Phase 2 clinical trial of its RP-323 in patients with acute myelocyti...