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sNDA for Ozempic Planned for Kidney Disease

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Novo Nordisk says it will file a supplemental NDA this year seeking an expanded label for Ozempic (semaglutide) for preventing pro...

FDA Approves Sandoz Prolia, Xgeva Biosimilars

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FDA approves Sandoz Jubbonti and Wyost, the first interchangeable biosimilars for Amgens Prolia and Xgeva.

Budget Compromise Gives FDA $160 Million Boost

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Senate and House appropriators post a joint spending bill agreement for fiscal year 2024 that would provide FDA with a $160 millio...

1st OTC Continuous Glucose Monitor Cleared

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FDA clears a Dexcom 510(k) for the companys Stelo Glucose Biosensor System, which the agency says is the first over-the-counter co...

Info Collection on FDA Drug Communications

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Federal Register notice: FDA sends to OMB an information collection extension entitled Data to Support Drug Product Communications...

Bell Intrnatl. Labs Warned Over CGMP Violations

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FDA warns Eagan, MN-based Bell International Laboratories about CGMP violations in its production of finished drugs.

CGMP Violations Found at Colgin

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FDA warns Dallas, TX-based Colgin, Inc., about CGMP violations in its production of finished drugs.

QS, MDR Violations at Fresenius Kabi Facility

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FDA warns Fresenius Kabi USA about QS and MDR issues at its North Andover, MA, facility that manufactures and distributes the Iven...

New Dietary Ingredient Notification Guidance

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FDA publishes a guidance on the procedures and timeframes for submitting a required New Dietary Ingredient Notification.

Comments on FDA Guidance Best Practices

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Four stakeholders respond to an FDA request for comment on guidance best practices.