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FDA Corrects Notice on Cigarette Package Warnings

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Federal Register Notice: FDA corrects a docket number in a Federal Register notice announcing the guidance on required warnings f...

J&J Files sNDA for Nucynta ER

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Johnson & Johnson Pharmaceutical Research & Development files a supplemental for Nucynta ER (tapentadol) seeking approval for mana...

FDA Panel Votes Down Medtronic Ablation Device

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An FDA advisory panel rejects a Medtronic PMA for its Phased RF Ablation System.

Dynavax Plans Early 2012 Hep B Vaccine BLA

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Dynavax Technologies says FDA has concurred with its plans to file a BLA early in 2012 on its Heplisav hepatitis B vaccine for per...

FDA OKs Medtronic IDE for ASPIRE Study

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FDA approves a Medtronic IDE to conduct a pivotal in-home clinical trial for the ASPIRE study involving the MiniMed Paradigm Syste...

FDA Clears Spinal USA Devices for Degenerative Disc Disease

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FDA grants 510(k) clearance to Spinal USA for Vault Stand Alone ALIF System for intervertebral body fusion of the spine in patient...

CVM Publishes Animal Antibiotic Sales Data for 2010

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CVM publishes its second annual report summarizing sales and distribution of antimicrobial drug products approved for use in food-...

FDA Orphan Drug Status for BiovaxID

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FDA grants Biovest International an orphan drug designation for BiovaxID for treating Waldenstrom's macroglobulinemia.

Gilead NDA for Quad in Treating HIV

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Gilead Sciences files an NDA for Quad, a single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil...

FDA Narrows Data Integrity Concern at CRO

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FDA says fewer NDA/ANDA bioanalytical studies will need to be repeated or confirmed based on earlier data integrity concerns at co...