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Ex-FDA Head Califf Moves Full-time at Alphabet

[ Price : $8.95]

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Federal Register notice: FDA makes available a draft guidance for industry #261 entitled Eligibility Criteria for Expanded Conditi...

FDA/DEA Warn Online Opioid Marketers

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FDA and the U.S. Drug Enforcement Administration issue joint Warning Letters to four online networks that were illegally marketing...

FDA Clears CivaTech Skin Cancer Patch

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FDA clears a CivaTech Oncology 510(k) for its CivaDerm, a radiation therapy bandage designed for intraoperative or surface radiati...

U.S. Specialty Formulations Cited on Inspection

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FDA posts an 11-item Form FDA-483 to U.S. Specialty Formulations after concluding an inspection of its Bethlehem, PA manufacturing...