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Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Apollo Health and Beauty Care.

Precigen Gains Orphan Status for CAR-T Therapy

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FDA grants Precigen an orphan drug designation for PRGN-3006, a first-in-class investigational therapy for treating patients with ...

PhotoniCare Middle Ear Scope Cleared

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FDA clears a PhotoniCare 510(k) for its TOMi Scope for non-invasive imaging of the middle ear.

FDA Clears Applied BioCode Respiratory Pathogen Panel

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FDA clears an Applied BioCode 510(k) for its BioCode Respiratory Pathogen Panel for use on the BioCode MDx-3000 System.

Vaccines/Biological Products Panel Meets 3/4

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Federal Register notice: FDA announces a 3/4 Vaccines and Related Biological Products Advisory Committee meeting to discuss upcomi...

Patient Engagement Panel Renewed for 2 Years

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Federal Register notice: FDA renews for two years the charter for its Patient Engagement Advisory Committee.

Pharmaceutical Science Panel Charter Renewal

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Federal Register notice: FDA has renewed for another two years the charter for its Pharmaceutical Science and Clinical Pharmacolog...

Viiv Healthcare Gets Complete Response on HIV NDA

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FDA sends ViiV Healthcare a complete response letter on its NDA for cabotegravir and rilpivirine, a long-acting regimen for treati...

FDA OKs Novo Nordisks Fiasp for Children

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FDA approves a Novo Nordisk NDA for Fiasp (insulin aspart injection) 100 u/mL as a mealtime insulin option for children with diabe...

Sun Pharma Gets 8-item FDA-483

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FDA issues Sun Pharmaceutical Industries an eight-observation Form 483 after a December inspection at its Gujarat, India drug manu...