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One-Third of BTD Requests Granted: Analysis

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CDER researchers say 39% of breakthrough therapy designation requests between 2017 and 2019 were approved by FDA.

Koru Medical Prefilled Syringe Pump Cleared

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FDA clears a Koru Medical Systems 510(k) for the Freedom60 Infusion System with Hizentra 50 mL prefilled syringes.

Orphan Status for Breast Cancer Radiotherapy

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FDA grants Plus Therapeutics an orphan drug designation for rhenium obisbemeda, an injectable radiotherapy for treating breast can...

Guide on Item Response Theory Clinical Data

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FDA releases a final guidance entitled Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using...

Guide on Device Export Certifications

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FDA reissues a guidance document entitled Process to Request a Review of FDAs Decision Not to Issue Certain Export Certificates fo...

Neurovalens Insomnia Neurostimulation Cleared

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FDA clears a Neurovalens 510(k) for its Modius Sleep neurostimulation device for treating chronic insomnia.

Foradil Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Novartis Foradil (formoterol fumarate) inhalation powder (.012 mg) was not withdrawn ...

CDRH Endorses Device Cybersecurity Standard

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CDRH says it has recognized and supports industrys use of a key consensus standard "ANSI/AAMI SW96:2023 Standard for medical devic...

Teleflex/Arrow Recall Catheter Kits

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Teleflex and subsidiary Arrow International recall their Pressure Injectable Catheter Kits due to mislabeling about the presence o...

Petition Seeks to Block Vigabatrin Exclusivity

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Law firm Sidley petitions FDA on behalf of an unnamed client asking that it not grant orphan-drug exclusivity to Pyros Pharmaceuti...