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Interim Record Request Communications Process

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FDA describes the interim communications process it will use for issues it finds when reviewing records or other information reque...

Woodcock: FDA at Inflection Point in Pandemic

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FDA acting commissioner Janet Woodcock tells the Food and Drug Law Institutes annual meeting that the agency is at a critical infl...

Revised Guide on Inspections During Covid

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FDA posts a revised guidance entitled Manufacturing, Supply Chain, and Drug and Biological Product Inspections During Covid-19 Pub...

Collaborations Needed to Advance Regulatory Science: FDA

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Two FDA officials update stakeholders online about agency efforts to improve its stakeholder and outside expert interactions to ad...

Former FDA Policy Head Lands at Akin Gump

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After four years at FDA, former FDA deputy commissioner for policy, legislation, and international affairs Anna Abram joins Akin G...

FDA Corrects CytoDyn Misinformation on Leronlimab

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In a rare step, FDA publicly corrects CytoDyn misinformation about an investigational therapy for treating Covid-19 patients.

Master Protocol Guide for Covid Therapies

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FDA issues a final guidance on master protocols for Covid-19 drugs and biologics.

MDIC Taps Booze Allen for Cybersecurity Help

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FDA and the Medical Device Innovation Consortium announce a partnership with Booz Allen Hamilton to establish a benchmark of the m...

Comments Sought Peptide Clin/Pharm Evaluations

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Federal Register notice: FDA opens a public docket for comments on Evaluating the Clinical Pharmacology of Peptides.

Ovide Not Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA determines that Taro Pharmaceutical Industries Ovide (malathion) lotion, 0.5%, was not withdrawn due ...