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Healthcare Technology Safety Bill Introduced

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Reps. Brooks and Trott introduce a bill creating a public-private partnership to protect Americans sensitive healthcare informatio...

FDA Priority Review for Boehringer Gilotrif sNDA

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In its fourth major decision since May for drug products aimed at non-small lung cancer (NSCLC), FDA accepts for priority review a...

Cardio Device Status Indicators Not 510(k) Exempt

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Federal Register correction: FDA corrects a final order entitled Medical Devices; Cardiovascular Devices; Classification of the Ad...

FDA Approves Respicardia PMA for Sleep Apnea

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FDA approves a Respicardia PMA for the Remed System as a treatment option for patients who have been diagnosed with moderate to se...

FDA Clears Roche Cobas C-diff Test

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FDA clears a Roche 510(k) for the Cobas C-diff Nucleic acid test for detecting the toxin B gene of toxigenic Clostridium difficile...

FDA Accepts Amgen sBLA for Prolia

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FDA accepts an Amgen supplemental BLA for Prolia (denosumab) for treating patients with glucocorticoid-induced osteoporosis.

FDA Gives Breakthrough Status for AstraZenecas Tagrisso

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FDA grants AstraZeneca a breakthrough therapy designation for Tagrisso (osimertinib) for the first-line treatment of patients with...

FDA Awards 6 Research Grants on Natural History Studies

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FDA awards six new research grants ($6.3 million) for natural history studies in rare diseases that are intended to evaluate how t...

Animal Generic Drug User Fee Reauthorization Meeting

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Federal Register notice: FDA announces a 11/2 public meeting entitled Animal Generic Drug User Fee Act.

FDA Clears Game Ready Orthopedic Rehab Device

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FDA clears a Game Ready 510(k) for its orthopedic rehabilitation device, the Med4 Elite.