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Info Collection on Device Pediatric Subpopulations

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Federal Register notice: FDA seeks comments on an information collection extension on a requirement for submitting certain pediatr...

21 No-longer-marketed ANDAs Withdrawn

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Federal Register notice: FDA withdraws approval of 21 ANDAs from multiple applicants after they notified the agency that the drug ...

FDA Orders GREFI to Stop Making Cell/Tissue Products

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FDA orders Gynecology, Reproductive Endocrinology and Fertility Institute to immediately stop manufacturing cell/tissue products a...

Workshop on Artificial Intelligence in Radiological Imaging

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FDA announces a 2/25 public workshop entitled Evolving Role of Artificial Intelligence in Radiological Imaging.

Review Period for Novo Nordisks Ozempic

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Novo Nordisks Ozempic.

Merck sBLA Accepted for Keytruda in Bladder Cancer

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FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), Mercks anti-PD-1 therapy as monotherapy for...

Lexicon Loses Appeal of FDA Complete Response

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FDAs Office of New Drugs denies a Lexicon Pharmaceuticals appeal of a March Complete Response Letter on its NDA for diabetes drug ...

Former FDA Commissioner Frank Young Dies at 88

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Former FDA commissioner Frank Young dies at age 88.

Tzvi Lexiere Debarred for 10 Years

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Federal Register notice: FDA debars Tzvi Lexier for 10 years from importing any drug into the U.S. because he was convicted for co...

Six ANDAs Withdrawn by FDA

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FDA withdraws approval of six ANDAs from multiple applicants after they notified the agency that the drug products were no longer ...