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FDA Awards 15 grants for Orphan Drugs

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FDA awards 15 grants totaling more than $14 million to boost rare disease product development.

FDA Seeks Injunction Against Oregon Supplement Maker

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FDA sues dietary supplement maker James G. Cole seeking a permanent injunction against its alleged promotion and distribution of u...

FDA Rejects Watson Petition on Rapaflo Bioequivalence

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FDA denies a Watson Labs citizen petition seeking additional bioequivalence requirements for generic applicants seeking approval t...

FDA Denies Petition Seeking Regs or Guidance on Shared REMS

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FDA denies a Prometheus citizen petition request to undertake notice and comment rulemaking to set standards and processes for sin...

Blood Thinners Top Drug Adverse Event Report List

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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...

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 ...

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...

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 ...