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Patient Access to At-Home Technologies

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CDRH asks for public comment on eight questions about using medical technologies in a home setting.

Doc Bought Oncology Meds to Sell for Profit: DoJ

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A New Jersey oncologist becomes the third doctor to plead guilty to participating in a scheme to purchase prescription oncology dr...

FDA Clears Ezra Flash AI for MRI Quality

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FDA clears an Ezra 510(k) for its artificial intelligence-enabled Ezra Flash and its use in enhancing MR image quality.

CDER Drug Policy Guru Heads to Morgan Lewis

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CDER Office of New Drug Policy director Maarika Kimbrell leaves the agency to re-enter private legal practice at Morgan Lewis as a...

CDRH Committee to Discuss Health Equity

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CDRH announces a 9/6 Patient Engagement Advisory Committee meeting to discuss and make recommendations on Advancing Health Equity ...

Sanofi Multiple Sclerosis Trial Meets Endpoint

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Sanofi says data from a Phase 2 trial of frexalimab significantly reduced disease activity in patients with relapsing multiple scl...

FDA Alert on Compounded Semaglutide

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FDA alerts patients and healthcare providers to concerns about compounded semaglutide that is being produced as an alternative to ...

CDER Risk, Safety Report for 2022 Issued

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The CDER Office of Surveillance and Epidemiology 2022 annual report highlights activities in public health emergencies, drug risk ...

FDA Limited in Managing Drug Shortages: Pazdur

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Oncology Center of Excellence director Richard Pazdur explains what FDA can and cant do to address cancer drug shortages.

FDA Inactivating Cell/Tissue Product Registrations

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Federal Register notice: FDA intends to inactivate the registration of establishments that manufacture human cells, tissues, or ce...