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FDA Updates Cybersecurity Playbook

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FDA says MITRE has updated a 2018 playbook explaining how healthcare organizations can prepare for and respond to cybersecurity in...

Certain Naloxone Products Could be OTC: FDA

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FDA is soliciting comments on a preliminary assessment that some naloxone products may be safe and effective when sold over-the-co...

FDA Questions Ardelyx Tenapanor

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FDA medical reviewers ask the Cardiovascular and Renal Drugs Advisory Committee to consider whether the benefits of Ardelyx tenapa...

Workshop on Using Consensus Standards in Device Submissions

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FDA announces a 12/7 public workshop on Appropriate Use of Consensus Standards to obtain public input on using these in premarket ...

1 Observation on Athenex Pharma FDA-483

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FDA releases the form FDA-483 issued following an inspection at the Clarence, NY-based Athenex Pharma Solutions outsourcing facili...

Comments on Computer Software Assurance Guidance

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Three stakeholders recommend broadening the impact of an FDA draft guidance on computer software assurance.

AdvaMed Tells FDA to Scrap LASIK Labeling Guidance

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AdvaMed says FDA should withdraw its draft guidance on LASIK patient labeling recommendations because the group has numerous conce...

Roche Molecular Gets EUA for Monkeypox Test

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FDA issues Roche Molecular Systems an emergency use authorization for its cobas MPXV monkeypox test.

FDA Clears Surgical Augmented Reality Software

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FDA clears a Xironetic 510(k) for its IntraOpVSP augmented reality (AR) visualization software for use in complex surgeries.

Protalix, Chiesi Resubmit Fabry Disease BLA

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Protalix BioTherapeutics and Chiesi Global Rare Diseases resubmit a BLA for PRX102 (pegunigalsidase alfa) for treating adult patie...