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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.

Lilly Attests to Quality Confidence at FDA-inspected Site

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Eli Lilly says it has a high degree of confidence in the quality of the active pharmaceutical ingredient made in Branchburg, NJ fo...

Sterile Drug Product Issues at Surgery Pharmacy Services

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FDA warns Surgery Pharmacy Services that it has been producing adulterated compounded drugs in insanitary conditions.

Info Collection on Device Tracking

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Federal Register notice: FDA seeks comments on an information collection extension for Medical Devices; Device Tracking 21 CFR Pa...

FDA Reviewers Support Biogens Aducanumab

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FDA medical reviewers give a generally positive assessment of Biogens aducanumab that is indicated to delay clinical decline in pa...

STAQ Pharma Inspection FDA-483 Released

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FDA releases an FDA-483 with five observations from an inspection at STAQ Pharma.