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GDUFA 3 Looks at Approving ANDAs Earlier

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FDA and the generic drug industry each offer proposals to advance quicker ANDA approvals.

Payments to Docs Correlate with ICD Choices: Study

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Researchers say there is a correlation between medical device company payments to doctors and the selection of defibrillator devic...

BMS Psoriasis Drug Posts Favorable Trial Results

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Bristol Myers Squibb announces positive results from POETYK PSO-1, a pivotal Phase 3 trial evaluating deucravacitinib, a novel, or...

Comments on Patient-Reported Outcomes Guidance

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Three stakeholders comment on an FDA draft guidance on using patient-reported outcomes in evaluating medical products.

FDA Service Delivery Feedback Info Collection Extension

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Federal Register notice: FDA sends to OMB an information collection extension for Generic Clearance for the Collection of Qualitat...

Info Extension on Strategic Stockpile Labeling

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Federal Register notice: FDA sends to OMB an information collection extension for Exceptions or Alternatives to Labeling Requireme...

CGMP Violations at Cosmax USA

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FDA warns Cosmax USA about CGMP violations in its production of finished drugs.

Digital Health Center of Excellence Roadmap Explained

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An FDA Webinar listening session discusses the role and operations of the new Digital Health Center of Excellence.

Medtronic Class 1 Recall of Rashkind Balloon Catheters

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Medtronic begins a Class 1 recall of its Rashkind Balloon Septostomy Catheters because of device quality issues that may lead to t...

Immusist Selling Unapproved, Misbranded New Drugs

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FDA warns Immusist that it is selling unapproved and misbranded new drugs.