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Merck BLA Filed for Pneumococcal Conjugate Vaccine

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Merck submits a BLA for V114, an investigational 15-valent pneumococcal conjugate vaccine for use in adults 18 years of age and ol...

Biden Impact on FDA Centers/Programs Analyzed

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Three Covington & Burling attorneys analyze how a Biden administration may make its mark on FDA Centers and programs.

Former Insys President Debarred by FDA

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Federal Register notice: FDA orders the permanent debarment of Michael L. Babich from providing services in any capacity to a pers...

FDA Wants More CMC Info for Liquidia LIQ861

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An FDA complete response letter tells Liquidia the agency needs more CMC data on the companys LIQ861 inhalation powder to treat pu...

FDA Support for U.S.-Mexico-Canada Trade Agreement

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FDA senior trade advisors outline reasons why the new U.S.-Mexico-Canada agreement is better for the agency and public health than...

HHS Withdrawing FDA Compliance Guide on Unapproved Drugs

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Federal Register notice: HHS announces its intent to withdraw FDAs Marketed Unapproved Drugs Compliance Policy Guide, Sec. 440.10...

Combination Product Jurisdiction Info Collection

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Federal Register notice: FDA sends to OMB an information collection revision entitled Product Jurisdiction and Combination Product...

Info Collection on Compounding Outsourcing Facilities

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Federal Register notice: FDA sends to OMB an information collection extension entitled Obtaining Information to Understand Challen...

3 Groups Sue to Block Drug Import Rule

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Three healthcare groups sue the Trump administration to block an HHS/FDA final rule that would permit some drug importation from C...

CGMP Issues at AuroLife Pharma New Jersey Facilities

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FDA warns AuroLife Pharma about CGMP violations at two of its New Jersey drug manufacturing facilities.