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FDA issues a draft guidance with recommendations for how companies can present quantitative efficacy and risk information in DTC h...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

CGMP Violations at Koreas Hanlim Pharm

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FDA warns South Koreas Hanlim Pharma about CGMP violations in its manufacturing of finished pharmaceuticals.

Afrezza Facebook Post False, Misleading: OPDP

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CDERs Office of Prescription Drug Promotion says a Facebook post about MannKinds Afrezza misbrands the drug by failing to adequate...

FDA Draft Guide on Rare Disease Pre-IND Meetings

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Federal Register notice: FDA makes available a draft guidance entitled Rare Diseases: Early Drug Development and the Role of Pre-I...

Class 1 Recall for Endologicx Endovascular AAA Device

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FDA classifies as a Class 1 recall an Endologix safety notice to healthcare professionals about its AFX Endovascular AAA [abdomina...