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Draft Guide on Hematologic Malignancies Drug Development

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Hematologic Malignancies: Regulatory Considerations for Use...

Guide on Targeted Therapies

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Federal Register notice: FDA makes available a final guidance entitled Developing Targeted Therapies in Low-Frequency Molecular Su...

Clinical Investigator Violations Cited

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FDA warns California doctor Ignatius Godoy about violations in his role as clinical investigator in a pediatric flu vaccine study.

Regulatory Considerations for Dialysis Catheters

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CDRH participates in a Kidney Health Initiative workgroup to explain regulatory considerations for central venous catheters for he...

FDA Wants Comments on Proposed DTC Study

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FDA asks for comments on proposed research looking at how consumers respond to disease awareness communications that accompany tel...

DTC Ad Efficacy and Risk Info Guidance

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FDA issues a draft guidance with recommendations for how companies can present quantitative efficacy and risk information in DTC h...

Pfizers Talzenna OKd for Breast Cancer

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FDA approves Pfizers Talzenna (talazoparib), a poly (ADP-ribose) polymerase inhibitor for certain patients with locally advanced o...

3-Factor Approach for Product Communications: FDA

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FDA outlines a three-factor approach it uses to evaluate whether a drug- or device-related product communication is consistent wit...

FDA Rejects TearLab 510(k) for Dry Eye Test

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FDA rejects a TearLab Corp. 510(k) for its TearLab Discovery MMP-9 test for dry eye disease.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Hanlim Pharm Co. and Ignatius P. Godoy.