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FDA Loses Court Case Over Generic Minocin

[ Price : $8.95]

The Washington DC District Court rules against FDA in granting summary judgment to plaintiff Melinta Therapeutics that suspends th...

FDA Proposes to Deny Hetlioz sNDA

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FDA explains why it is proposing to refuse to approve a Vanda sNDA for a new indication for Hetlioz.

Drug Outsourcing Group/FDA Settle Law Suit

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The Outsourcing Facilities Association and FDA reach a settlement agreement that compels the agency to promptly review long-pendin...

Marked Change Seen in FDA Final CDS Guidance

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Hyman, Phelps & McNamara attorneys and a medical device regulatory expert say an FDA final guidance on clinical decision support s...

More Quality Issues at Lilly Plant: Reuters

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Reuters reports that FDA has again found quality issues at the Lilly Branchburg, NJ, drug manufacturing facility.

Priority Review for Gilead Trodelv sBLA

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FDA accepts for priority review a Gilead Sciences supplemental BLA for Trodelv (sacituzumab govitecan-hziy) for treating certain a...

CGMP Violations at Mexicos Eksa Mills

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FDA warns Mexicos Eksa Mills about CGMP violations in its manufacturing of finished drugs.

EUA Revoked For Covid-19 Test

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Federal Register: FDA revokes an emergency use authorization issued to Laboratorio Clinico Toledo, Puerto Rico, for its Laboratori...

Dupixent Filing for Eosinophilic Esophagitis Next Year

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Regeneron Pharmaceuticals and Sanofi say they will seek FDA approval next year for Dupixent (dupilumab) and its use in treating ch...

Draft Guide on ANDA Facility Inspection Readiness

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Federal Register notice: FDA makes available a draft guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA.