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Feedback Sought on Integrated Review Document

[ Price : $8.95]

FDA seeks comments on the use of its Integrated Review document as it decides to expand its use beyond new molecular entities, ori...

FDA Publishes 8th Revision of Electronic Format Guide

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FDA publishes the eighth revision of a guidance on providing regulatory submissions for certain drug products in electronic format...

Apple AirPods Hearing Software Authorized

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FDA authorizes Apples Hearing Aid Feature software to use with compatible AirPods Pro headphones to operate as an over-the-counter...

Tremfya Secures Approval for Ulcerative Colitis

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FDA approves Johnson & Johnsons Tremfya (guselkumab) for treating adults with moderately to severely active ulcerative colitis.

Gilead Positive on Twice-Yearly HIV Drug Data

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Gilead Sciences says data from a second pivotal Phase 3 clinical trial investigating its twice-yearly injectable lenacapavir show ...

GSK Moves mRNA Flu Vaccine to Phase 3

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GSK moves its mRNA seasonal influenza vaccine program into Phase 3 after reporting favorable Phase 2 data.

Panel to Review ProSense Cryoablation De Novo Request

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Federal Register notice: FDA announces an 11/7 advisory committee meeting to review an IceCure Medical de novo request for its Pro...

FDA Veozah Liver Injury Warning

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FDA says it has added a Warning to labeling for Astellas Veozah about the risk of rare but serious liver injury.

Recommendations on Rare Disease Collaboration

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A new National Academies book on collaboration in rare disease drug development lists steps it recommends that FDA take.

GDUFA ANDA Amendment Submissions

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FDA publishes a guidance on submitting ANDA amendments under GDUFA 3.