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Blood Thinners Top Drug Adverse Event Report List

[ Price : $8.95]

Adverse event reports associated with blood thinners Pradaxa (dabigatran) and warfarin top the list of drug safety problems report...

MiMedx Reschedules FDA Meeting on Untitled Letter

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MiMedx Group and FDA reschedule a meeting to discuss a recent Untitled Letter the firm received requiring it to obtain a BLA to la...

FDA Approves Actelion NDA for Opsumit

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FDA approves an Actelion Pharmaceuticals NDA for Opsumit (macitentan) for treating pulmonary arterial hypertension to delay diseas...

Ariad Scraps Phase 3 Iclusig Trial Due to Safety

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Ariad Pharmaceuticals stops its Phase 3 EPIC trial involving Iclusig (ponatinib) in patients with newly diagnosed chronic myeloid ...

AdvaMed Urges Separate Communications on Device Trial Concerns

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AdvaMed says FDA should send future considerations and other concerns about an IDE-approved clinical trial to sponsors in separate...

FDA Sends 2nd Complete Response Letter on Iluvien NDA

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FDA sends pSivida another complete response letter on a resubmitted NDA for Iluvien (fluocinolone acetonide) for treating chronic ...

Guidant Agrees to Pay $30 Million on Defective Devices

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Boston Scientific and its Guidant subsidiary agree to pay $30 million to settle government allegations that Guidant knowingly sold...

Device Reporting Guidance Has Unwarranted Requirements: WLF

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Washington Legal Foundation says an FDA proposed guidance on medical device reporting imposes new requirements on manufacturers th...

FDA 510(k) Guidance Needs Significant Changes: Consultant

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Speakers at a Washington Legal Foundation briefing outline significant problems they see with FDAs draft guidance on the 510(k) pa...

FDA Extends Feraheme sNDA Review by 3 Months

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FDA extends by three months its review of an AMAG Pharmaceuticals supplemental NDA for Feraheme (ferumoxytol) injection for intrav...