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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.

CDER Quantitative Medicine CoE Explained

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CDER Quantitative Medicine Center of Excellence lead Rajanikanth Madabushi explains the new units role in drug development and reg...

GDUFA ANDA Amendment Submissions

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