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Drug Quality Assessments Guidance

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Federal Register notice: FDA makes available a draft guidance entitled Benefit-risk Considerations for Product Quality Assessments...

Eisai BLA for Alzheimers Therapy

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Eisai files a rolling BLA submission under the accelerated approval pathway for its investigational anti-amyloid beta protofibril ...

CGMP Violations at Brigham and Womens Hospital

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FDA warns Boston, MA-based Brigham and Womens Hospital about CGMP violations in its production of positron emission tomography dru...

FDA Accelerating Rare Disease Cures Program

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CDER launches its new Accelerate Rare disease Cures program to speed and increase the development of effective and safe treatment ...

Mesa Biotech Covid-19 Test Recalled

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Mesa Biotech recalls its Accula SARS-CoV-2 Test because certain lots of the device have an increased risk of giving false positive...

Inhousepharmacy Selling Illegal Unapproved Drugs: FDA

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FDA warns inhousepharmacy.vu that it is illegally marketing domperidone drug products in the U.S.

Dont Use Skippack Covid Rapid Test: FDA

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FDA says the Skippack Medical Laboratory recall of rapid Covid-19 tests that were not cleared, approved, or authorized is Class 1 ...

Committee Documents Emergent Manufacturing Failures

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A House committee staff report blasts Emergent Biosolutions for hiding its Covid-19 vaccine manufacturing problems from FDA and HH...

Lillys Olumiant Approved for Covid-19

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FDA approves a new indication for Eli Lillys Olumiant (baricitinib) for treating Covid-19 in hospitalized adults requiring supplem...

FDA Revokes EUAs on 2 Covid Tests

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FDA revokes a Bio-Rad Laboratories Emergency Use Authorization (EUA) and a Bio- Applied DNA Sciences EUA for their no-longer-distr...