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Ashley Retiring as CDER Compliance Director

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FDA announces the retirement of CDER Office of Compliance director Don Ashley.

FDA Looking at Marijuana Scheduling Flexibility: Woodcock

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FDA principal deputy commissioner Janet Woodcock says the agency is exploring what flexibility it has in reviewing the science and...

EUA Granted for Abbott Monkeypox Diagnostic

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Federal Register notice: FDA announces an Emergency Use Authorization for Abbott Molecular and its Alinity m MPXV monkeypox diagno...

Guide on C-diff Infection Drug Development

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FDA makes available a draft guidance entitled Clostridioides difficile Infection (CDI): Developing Drugs for Treatment, Reduction ...

FDA Advancing Treatments for Children

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FDA officials list ways in which the agency is promoting the development of pediatric medicines.

FDA Questions Y-mAbs Neuroblastoma Treatment Efficacy

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FDA raises efficacy questions about a Y-mAbs BLA for I-omburtamab to treat pediatric patients with CNS/leptomeningeal metastases f...

Digital Health Regulatory Science Opportunities

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The CDRH Digital Health Center of Excellence releases a document highlighting topics of interest for regulatory science research a...

GSK Scraps Monoclonal Antibody Development for RA

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GSK decides not to seek FDA approval for otilimab, an investigational monoclonal antibody targeting granulocyte-macrophage colony-...

Info Collection on 3rd Party Review Program

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Federal Register notice: FDA sends to OMB an information collection extension entitled 510(k) Third-Party Review Program.

Positive Results in AZ Breast Cancer Trials

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AstraZeneca reports positive results from two trials evaluating new breast cancer treatments.