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Mpox Product Development Guidance

[ Price : $8.95]

FDA posts a draft guidance entitled Mpox: Development of Drugs and Biological Products.

FDA Seeks Injunction Against LGM Pharma

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FDA asks a Florida federal court for an injunction against LGM Pharma to ensure that it no longer holds and ships adulterated drug...

11 Observations on Intas Pharmaceuticals FDA-483

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FDA releases the form FDA-483 with 11 observations from an inspection at Indias Intas Pharmaceuticals.

Realize Medical Virtual Reality Surgical Tool Cleared

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FDA clears a Realize Medical 510(k) for its Elucis virtual reality software for surgical planning.

Fix the Evidence Generation System Now: Califf

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FDA commissioner Robert Califf says FDA has a key role to play in reshaping the nations system for generating medical evidence to ...

Lilly Alzheimers BLA Rejected by FDA

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FDA sends Eli Lilly a complete response letter for its accelerated approval BLA submission for donanemab, indicated for treating e...

Info Collection on Device Adverse Event Program

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Federal Register notice: FDA seeks comments on an information collection extension entitled Adverse Event Program for Medical Devi...

Info Collection on Informed Consent, IRB Role

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Federal Register notice: FDA sends to OMB an information collection extension entitled Protection of Human Subjects; Informed Cons...

Mend Lax Clinical Trial Reporting: Pallone

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Rep. Frank Pallone asks FDA and NIH what they are doing to enforce compliance with ClinicalTrials.gov reporting requirements.

FDA Denies Fresenius Glycopyrrolate Petition

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FDA denies Fresenius Kabis request that its glycopyrrolate solution receive a therapeutic equivalent rating with Hikmas Robinul.