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FDA Extends Review of Lipocine Testosterone Product

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FDA extends its review of a Lipocine NDA resubmission for Tlando, an oral testosterone product candidate for hormone replacement t...

Nostrum Recalls Some Metformin for NDMA Contamination

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FDA says Nostrum Laboratories has recalled four lots of metformin due to potential NDMA contamination.

Comments Sought on FDA Posting REMS Assessments

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Federal Register notice: FDA establishes a docket to solicit public comment on a proposal to publish a summary of FDAs review of R...

FDA Accepts BioMarin Vosoritide NDA

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FDA sets 8/20/21 as the PDUFA action date for BioMarins vosoritide NDA to treat children with achondroplasia.

Bluebird Bio Readying BLAs

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Bluebird Bio reaches agreement with FDA on issues related to its submission of a BLA for LentiGlobin to treat sickle cell disease....

FDA Accepts for Review AstraZeneca Lupus Therapy

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FDA accepts for review AstraZenecas anifrolumab, an investigational drug for treating moderate to severe systemic lupus erythemato...

Workshop on Opioid REMS Education Program

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Federal Register notice: FDA announces a 12/11 public workshop entitled Evaluating the Effect of the Opioid Analgesics Risk Evalua...

FDA Approves Chiesi USAs Bronchitrol

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FDA approves Chiesi USAs Bronchitrol as a cystic fibrosis add-on maintenance therapy.

Manufacturing/Inspections Discussed Under Next PDUFA

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FDA and drug industry representatives explore manufacturing and inspection interests as part of their Prescription Drug User Fee A...

FDA Schedules an Opioid REMS Workshop

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FDA announces a 12/11 virtual public workshop on methods to evaluate the opioid analgesic REMS education program.