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Pozen Responds to Approvable Letter on Migraine Drug

[ Price : $8.95]

Pozen says it has submitted a full response to a recent approvable letter on migraine drug Trexima.

Chinese Manufacturer Warned on API Problems

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FDA warns Chinas Northeast General Pharmaceutical Factory on cGMP deviations at its Shenyang API manufacturing facility

Premarin-Cancer Case Dismissed

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A Minnesota judge dismisses a suit claiming Wyeths Premarin and Prempro caused breast cancer for lack of scientifically valid evid...

FDA Clears Bone Marrow Harvester

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FDA clears a StemCor Systems 510(k) for the MarrowMiner, intended for use in harvesting bone marrow.

Guidance on Advisory Panel Members Financial Information

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Federal Register Notice: FDA releases a draft guidance on public availability of advisory committee members financial interest inf...

Most Effective DTC Messages Deal with Symptoms

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MedTrackAlert says consumers respond best to ads that are relevant and deal with disease symptoms.

FDA OKs Allergans Combigan for Glaucoma

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FDA approves an Allergan NDA for Combigan, indicated for reducing elevated intraocular pressure in patients with glaucoma or ocula...

BioDelivery Sciences Submits Fentanyl NDA

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BioDelivery Sciences International submits an NDA for Bema (fentanyl), indicated for treating breakthrough cancer pain.

Satraplatin Fails Pivotal Trial

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GPC Biotechs satraplatin fails to meet the overall survivability endpoint of its Phase 3 hormone-refractory prostate cancer pivota...

Guidance on HIV Resistance Testing

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Federal Register Notice: FDA releases a guidance on the role of HIV resistance testing in antiretroviral drug development.