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CGMP Violations in GC America Inspection

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FDA warns Alsip, IL-based GC America about CGMP violations in its production of finished drugs.

AstraZeneca Breast Cancer NDA Review Extended by FDA

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FDA extends its review of an AstraZeneca NDA for camizestrant, an experimental breast cancer therapy, after requesting additional ...

Corcept Plans Resubmission of Cushings NDA

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Corcept Therapeutics plans to resubmit its NDA for relacorilant as a treatment for patients with Cushings syndrome, following addi...

AbbVies NDA for Dendritic Cell Neoplasms Approved

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FDA approves an AbbVie NDA for Decnupaz (pivekimab sunirine-pvzy) and its use in treating adults with blastic plasmacytoid dendrit...

FDA-483 Response Can Influence Future Agency Action: Post

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NSF consultants report on a webinar discussing the best practices in responding to inspection observations in a form FDA-483.

Objectionable Conditions in Dr. Adnan Dahdul's Clinical Trial

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FDA warns Springfield, MA-based physician Adnan Dahdul about Bioresearch Monitoring violations in his conduct of a clinical invest...

Info Request Period on AI Use in Early Trials Extended

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FDA extends by 30 days the comment period on a request for information entitled AI-Enabled Optimization of Early-Phase Clinical Tr...

Lilly Loading Up Vaccines Plate for Former CBER Head Marks

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Eli Lilly says it is acquiring three vaccine developers in deals worth up to $3.8 billion combined, expanding its push into infect...

India OTC Drug Manufacturer Slapped With Form-483

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FDA cites Dabur India Limited for significant manufacturing and data integrity violations at an over-the-counter drug manufacturin...

Low PCCP Use Could be Missed Opportunity: Study

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Researchers say manufacturers could make better use of predetermined change control plans for AI-enabled medical devices.