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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.

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.

Final Guide on Drug Development Tools

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FDA posts a final guidance on Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff.

Alnylam Pharma NDA for Oxlumo Approved

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FDA approves an Alnylam Pharmaceuticals NDA for Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria Type 1 (PH1), ...

ANDA Complex Product Meeting Guidance

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FDA issues a guidance to assist ANDA applicants for complex products to schedule and conduct several types of meetings with agency...