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J&J Responding to Coronavirus Crisis

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Johnson & Johnson says its Janssen unit is cooperating with regulators, healthcare organizations, and others in a multi-pronged ef...

Hypertension Indication Labeling Guidance

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FDA issues a guidance to help applicants develop labeling information demonstrating the connection between antihypertensive drugs ...

Insulin Product Clinical Immunogenicity Guidance Comments

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Stakeholders generally support the FDA position on clinical immunogenicity studies for biosimilar and interchangeable insulin prod...

CDER Proposing 80 Guidances in 2020

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CDER issues a list of 80 new and revised draft guidances it plans to publish in 2020.

FDA Revises Generic Drug Review Priority Policy

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FDA revises the CDER MAPP dealing with the review of ANDAs, amendments, and supplements.

FDA Denies Public Citizen Hetlioz Petition

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FDA denies a Public Citizen petition seeking a narrower indication and labeling changes for Vanda's Hetlioz sleep disorder drug.

Court Orders $344 Million in J&J Pelvic Mesh Case

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The California Superior Court orders Johnson & Johnson to pay $343.99 million in penalties for false and deceptive marketing of it...

Deviations from HCT/P Regs Found at R&B Medical

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FDA warns R&B Medical Group about HCT/P deviations in its work as a contract testing laboratory.

Voting Members Needed for CDRH Patient Panel

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Federal Register notice: FDA requests nominations for voting members to serve on CDRHֺֺs Patient Engagement Advisory C...

16 Information Collections Cleared by OMB

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Federal Register notice: FDA posts a list of 16 information collections approved by OMB.