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Explain Need for Trial Diversity: Caplan

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New York University bioethicist Arthur Caplan says those calling for greater diversity in clinical trials should clearly explain t...

FDA 5-Year Plan to Treat Diseases Like ALS

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FDA issues a five-year action plan for fostering and advancing drug development for rare neurodegenerative diseases such as ALS.

Accelerated Approval for Novartis Combo Therapy

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FDA grants Novartis accelerated approval for Tafinlar (dabrafenib) plus Mekinist (trametinib) for treating certain patients six ye...

Food Effects Guidance

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FDA publishes a guidance on clinical pharmacology considerations in assessing food effects in INDs and NDAs.

Dear Doctor Letters Info Collection Extension

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Federal Register notice: FDA seeks comments on an information collection extension entitled Improving Communication of Important S...

Breakthrough Therapy Rescission Guidance

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FDA publishes a draft guidance explaining how it periodically assesses drugs that have been granted breakthrough therapy designati...

Rigorously Scrutinize Accelerated Approval Program: Kumar

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University of Illinois psychiatry professor Anand Kumar calls on FDA to closely reevaluate the accelerated approval program to be ...

Medtronic Class 1 Recall of HeartWare HVAD Batteries

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Medtronic recalls (Class 1) one lot of batteries for its HeartWare Ventricular Assist Device due to welding defects that allow sep...

House Appropriators Approve $341 Million FDA Boost for 2023

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The House Appropriations Committee votes 31 to 26 to approve an FDA spending bill for fiscal year 2023 that will boost the agencys...

FDA Clears Medtronic LigaPASS

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FDA clears the Medtronic LigaPASS ligament augmentation system.