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FDA issues a draft guidance with recommendations for how companies can present quantitative efficacy and risk information in DTC h...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

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Federal Register notice: FDA makes available a draft guidance entitled Rare Diseases: Early Drug Development and the Role of Pre-I...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

Civco Radiotherapy for Immobilization System

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FDA clears a Civco Radiotherapy 510(k) for its Solstice SRS Immobilization System.

Untitled Letter on Web Site Product Promotion

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CBER sends an untitled letter to the operator of two Web sites http://www.ollereg.com and http://www.innovativeallergy.com becau...

FDA Approves EyePoint Pharma Uveitis Drug

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FDA approves EyePoint Pharmaceuticals Yutiq (fluocinolone acetonide intravitreal implant) for treating chronic non-infectious uvei...