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Info Collection on Device Corrections and Removals

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Federal Register notice: FDA sends to OMB an information collection on medical device corrections and removals reporting.

Trump Lifts Lab Tests from Need to Get OK from FDA

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A new Trump Administration initiative exempts laboratory-developed tests, including those for Covid-19, from the need to get FDA p...

Hahn Reassures Public in TV Appearance

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FDA commissioner Stephen Hahn tells a Michigan TV station that the agency is not under any political pressure to speed approval of...

FDA Multifunctional Device Guidance Explained

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Ropes & Gray attorneys outline key provisions in an FDA final guidance on multiple function medical devices.

False or Misleading Claims, Representations in Gvoke Ad

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The CDER Office of Prescription Drug Promotion says a TV ad for Xeris Gvoke fails to provide important risk information but misrep...

Bayer Warned About FDA Essure Scrutiny: Report

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Bloomberg News says a Bayer product surveillance senior manager warned the company that FDA would be notice an increase in adverse...

Novartis Kesimpta Approved for Multiple Sclerosis

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FDA approves a Novartis NDA for Kesimpta (ofatumumab) for subcutaneous use to treat relapsing forms of multiple sclerosis.

Breast Implant Adverse Events Updated

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FDA updates its alert on breast implant adverse events to include new reports received through 1/5 an increase of 160 new cases a...

HCTZ Safety Labeling Change

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FDA reports a slightly increased risk of non-melanoma skin cancer in patients taking the diuretic hydrochlorothiazide.

FDA Customer Service Surveys Info Collection

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Federal Register notice: FDA sends to OMB and information collection extension for Customer/Partner Service Surveys.