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Imbruvica Approved for Leukemia and Lymphoma

[ Price : $8.95]

FDA approves an AbbVie supplemental NDA for Imbruvica (ibrutinib) in combination with rituximab for the first-line treatment of pa...

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Tenderneeds Fertility.

Nonbinding Feedback Guidance

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FDA publishes a final guidance with a standardized method for device establishments to communicate and submit nonbinding requests ...

Kessler Calls for New Social Contract on Covid-19

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Likening Covid-19s threat to civilization to World War II, former FDA commissioner David A. Kessler calls for a new social contrac...

Guide on Temporary Pharmacy Compounding

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FDA posts a guidance on a temporary policy for compounding of certain drugs for hospitalized patients by pharmacy compounders not ...

Device User Fee Meeting Postponed

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Federal Register notice: FDA postpones until further notice a 5/5-scheduled public meeting entitled Medical Device User Fee Amendm...

EUA Templates to Speed Serology Tests: FDA

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FDA says it is working on emergency use authorization templates that laboratories and commercial manufacturers may use to facilita...

Avet Pharma Recalls Tetracycline HCl Capsules

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Avet Pharmaceuticals recalls several lots of tetracycline HCl capsules, 250 mg and 500 mg, 100-count bottles due to low out-of-spe...

Nova Botanix Warning on Unapproved Virus Products

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FDA warns Nova Botanix that its CBD products are being marketed for unapproved drug uses in treating or preventing Covid-19.

FDA Approves Pemazyre for Cholangiocarcinoma

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FDA approves an Incyte Corp. NDA for Pemazyre (pemigatinib) for treating adults with certain types of previously treated, advanced...