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Multiple Repeat Violations in Lupin Inspection

[ Price : $8.95]

FDA warns Lupin about CGMP violations and deviations at one of its units that are similar to those found in other Lupin facilities...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Lupin Limited, Shanghai Institute of Pharmaceutical Industry, Derma...

Heron Resubmits NDA for Pain Drug

[ Price : $8.95]

Heron Therapeutics resubmits an NDA for HTX-011, an investigational agent for managing postoperative pain.

Ex-FDA Head Califf Moves Full-time at Alphabet

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Former FDA commissioner Robert Califf accepts a full-time role at Alphabet Company as the head of medical strategy and policy for ...

Luminex 510(k) Cleared for Aries MRSA Assay

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FDA clears a Luminex 510(k) for the Aries MRSA Assay, a real-time, polymerase chain reaction-based, in vitro diagnostic test for d...

Shanghai Institute Refused FDA Inspection

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FDA warns Chinas Shanghai Institute of Pharmaceutical Industry that the agency may withhold approval of ANDAs or supplements listi...

Edits Suggested for BEST Taxonomy

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Four pharmaceutical stakeholders suggest edits to the FDA BEST glossary of biomarker, endpoints, and other tools.

Complete Response Letter for AZ COPD Drug

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AstraZeneca says it will work closely with FDA on next steps after receiving a complete response letter for its PT010 experimental...

Fee for Tropical Disease Priority Review Voucher

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Federal Register notice: FDA announces the fee rate of $2,167,116 for using a tropical disease priority review voucher for fiscal ...

Guide on Animal Drug Expanded Conditional Approval

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Federal Register notice: FDA makes available a draft guidance for industry #261 entitled Eligibility Criteria for Expanded Conditi...