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Tripartite Meeting Looks at Antibacterial Regulation

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Representatives from FDA, the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency are working on...

Equipment Contamination Seen in 2 Aurobindo Inspections

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Indias The News Minute says FDA inspections at two Aurobindo drug manufacturing facilities raised concerns about equipment contami...

Conformis Hip System Cleared

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FDA clears a Conformis 510(k) for its Conformis Hip System.

FDA Needs AI Standards: Executive

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Charles Fisher, who founded an artificial intelligence company that works in drug clinical trials, urges FDA to develop a framewor...

FDA in 2 Collaborative Communities

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CDRHer Michelle Tarver says FDA is participating in two collaborative communities and wants to be in 10 by the end of 2020.

FDA Clears Dx 360 Rotatable Disposable Sheath

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FDA clears a UVision360 510(k) for the 3mm Luminelle Dx 360 Rotatable Disposable Sheath, an attachment for the Luminelle DTx Hyste...

Recommendations for Neonatal Pharmacology Guidance

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Four stakeholders praise and recommend changes to an FDA draft guidance on general clinical pharmacology considerations for neonat...

CDER Office of Hematology, Oncology Products Reorganized

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CDER has completed reorganization of the Office of Hematology and Oncology Products into the Office of Oncologic Diseases.

Safety Surveillance Best Practices Draft

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FDA posts for comment a draft document with best practices for agency staff in conducting postmarket safety surveillance of drugs ...

Senate Sets 11/20 FDA Confirmation Hearing

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The Senate Health, Education, Labor & Pensions Committee schedules an 11/20 confirmation hearing for FDA commissioner nominee Step...