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Guide on Product Shortage Reporting Responsibility

[ Price : $8.95]

FDA posts a guidance on Notifying FDA about a medical product discontinuance or interruption in manufacturing.

Clinical Trial Challenges from Covid-19: Q & A

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FDA issues an updated guidance entitled Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic to add an appendix...

Zolls TherOx System OKd for Heart Damage

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FDA approves a Zoll Medical PMA for the TherOx System, which provides supersaturated oxygen therapy to reduce heart muscle damage ...

Emergency Use for Battelle Mask Decontaminator

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Battelle gains an emergency use authorization for its Critical Care Decontamination System for decontaminating respirator masks.

Eli Lilly sBLA OKd for Taltz

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FDA approves an Eli Lilly supplemental BLA for Taltz (ixekizumab) injection, 80 mg/mL, for treating pediatric patients with modera...

Info Request on Combo Product Designations

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Federal Register notice: FDA seeks comments on an information collection extension related to its guidance entitled Combination Pr...

Dr. Reddys Recalls Shattering Phytonadione Ampules

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Dr. Reddys Laboratories recalls four lots of phytonadione injectable emulsion, 10 mg/mL single-dose ampules due to the potential f...

Guide on Drug/Biologic Manufacturing Disruptions

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FDA releases a guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C o...

Guidance on CDRH Appeals Process Q & A

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FDA releases a guidance entitled Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About ...

FDA Warns Carahealth on Unapproved Virus Therapy

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FDA sends Warning Letter to Carahealth (Galway, Ireland) objecting to herbal products being offered online for treating Covid-19 p...