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FDA Draft Guidance on Responses to FDA-483s Explained

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Two Akin attorneys review a 3/9 FDA draft guidance recommending ways in which it would like to see human and drug manufacturers re...

FDA Rejects Aldeyras Dry Eye Drug Reproxalap

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FDA sends Aldeyra a complete response letter for its investigational dry eye treatment reproxalap, concluding that the company fai...

FDA Extends Review of Lantheus PET Imaging Agent

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FDA extends by three months its review of a Lantheus Holdings NDA for LNTH-2501, a diagnostic imaging agent targeting neuroendocri...

Senators Demand HHS Reverse Autism-Related Web Site Changes

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A group of U.S. senators is pressing HHS to reverse recent changes to FDA and other federal health Web sites, warning that altered...

FDA Flags Sterility, Contamination Control Issues at India Plant

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FDA inspectors cite multiple manufacturing and quality control deficiencies at a Gland Chemicals Private Limited in Chennai, India...

FDA Updates Internal Procedures for Handling Supplements

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FDA updates an internal policy document outlining how CBER staff process supplements to approved drug and biologic applications.

FDA Will Review Ketamine-Based Drug Without New Trials: NRx

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NRx Pharmaceuticals says FDA has indicated it is willing to review a potential NDA for its investigational therapy NRX-100 without...

NovaBridge Says FDA Open to Accelerated Approval for Givastomig

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FDA has told NovaBridge Biosciences that its investigational cancer therapy givastomig could be eligible for an accelerated approv...

FDA Accepts Sun Pharma Filing to Expand Ilumya Use

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FDA accepts for review a Sun Pharmaceutical Industries supplemental BLA seeking to expand the use of Ilumya (tildrakizumab-asmn) t...

Telix Resubmits NDA for Brain Cancer Imaging Agent Pixclara

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Telix Pharmaceuticals refiles an NDA seeking approval of its investigational PET imaging agent Pixclara (TLX101-Px, also known as ...