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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.

FDA, Federal Prosecutors Take Tougher Stance on Safety Reporting: Analysis

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A Cooley legal analysis notes that FDA and federal prosecutors are signaling a tougher stance on failures to report patient safety...

Seismic Loper Bright Impact Not Yet Seen: Attorneys

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A Yale Journal on Regulation article from the Yale Law School Solomon Center for Health Law & Policy examines how the Supreme Cour...

Alchymars ICM SM Inspection Issues

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FDA warns Indias Alchymars ICM SM Private Limited about CGMP deviations in its production of active pharmaceutical ingredients.

CGMP Issues at Japans Sato Pharmaceutical Co.

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FDA warns Japans Sato Pharmaceutical Co. about CGMP violations in its production of finished over-the-counter drugs.