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FDA: We Need 55 Years for Pfizer Vaccine Info Request

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FDA tells a Texas federal court it needs until 2076 to respond to a Public Health and Medical Professionals for Transparency reque...

FDA OKs Resumption of Enrollment in Masitinib Trial

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FDA says AB Science can resume enrollment of ALS patients in a Phase 3 study of masitinib.

Fast Track for Zentalis Uterine Carcinoma Drug

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FDA grants fast track designation to a Zentalis investigative drug for uterine serous carcinoma.

Alzheimers Treatment, Diagnostic Registry Launched

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The Alzheimers Association and other stakeholders are launching a national registry for Alzheimers diagnostic and treatment inform...

Meeting the 510(j)(3) Reporting Requirement

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Two Wiley Rein attorneys suggest ways companies could approach the new FDA section 510(j)(3) drug reporting requirement.

SterRx Recalls 240 Drug Lots Over Sterility

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SterRx recalls 240 lots of various drug products within their expiry period due to equipment and process issues that could lead to...

FDA Clears Pantheris for In-stent Restinosis

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FDA clears an Avinger 510(k) for a new clinical indication for the Pantheris image-guided atherectomy system treating in-stent re...

FDA Qualifies MED Institute MRI Safety Tool

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FDA qualifies the MED Institutes medical device development tool for virtual MRI safety evaluations of patients with implanted med...

FDA Clears MIM Molecular Radiotherapy Software

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FDA clears a MIM Software 510(k) for its MIM SurePlan MRT, a software package for molecular radiotherapy.

18 No-Longer-Marketed ANDAs Withdrawn

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Federal Register notice: FDA withdraws approval of 18 ANDAs from multiple applicants after they notified the agency that the drugs...