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14 GenoGenix Inspection Observations

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FDA releases the form FDA-483 containing 14 observations from an inspection at the GenoGenix outsourcing facility in Boca Raton, F...

Sanofi Dermatitis Drug Meets Endpoints in Study

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Sanofi says its investigational antibody amlitelimab met all primary and key secondary endpoints in a late-stage trial of patients...

RFK Jr. Grilled at Heated Senate Hearing

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Bipartisan criticism of Health and Human Services secretary Robert F. Kennedy Jr. dominates a contentious three-hour Senate Financ...

No Committee for Aquestives Anaphylm

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FDA says an advisory committee is not needed to discuss the Aquestive NDA for Anaphylm to treat severe allergic reactions.

FDA Pledges Prompt CRL Release

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FDA releases 89 previously unpublished complete response letters and says future letters will be released immediately after transm...

Medtronic Recalls DLP Left Heart Vent Catheters

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Medtronic Perfusion Systems recalls (Class 1) its DLP Left Heart Vent Catheters (malleable body and vented connector) because the ...

FDA Posts Alopecia Complex Case Study

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FDA posts a drug complex innovative design case study for a higher dose of an alopecia areata drug that did not assign participant...

Prasad Has Covid YouTube Videos Pulled

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The Guardian says CBER director Vinay Prasad successfully had videos of him criticizing Covid vaccines removed from the YouTube ch...

Boehringer Gets Breakthrough Status for Hernexeos

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FDA grants Boehringer Ingelheim a breakthrough therapy designation for Hernexeos (zongertinib) tablets for the first-line treatmen...

FDA Rare Disease Evidence Principles

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CDER and CBER launch the Rare Disease Evidence Principles process intended to bring greater speed and predictability to the review...