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FDA Clears Elekta 510(k) for Proton Therapy

[ Price : $8.95]

FDA clears an Elekta 510(k) for its XiO treatment planning software to plan the proton therapy delivery method, spot scanning.

Guidance for Blood Establishments

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Federal Register Notice: FDA releases a guidance on recommendations for blood establishments to train back-up personnel, assess bl...

FDA Extends Review for Lupus BLA

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FDA extends by three months the review of a Human Genome Sciences BLA for Benlysta (belimumab), indicated for treating systemic lu...

Ex-Sebelius Aide Purges FDA Press Office

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In an unprecedented purging of career staff under her, new FDA associate commissioner for external affairs Beth Martino, 31, remov...

FDA Panel Backs Fecal Incontinence PMA

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FDA's Gastroenterology and Urology Devices Panel votes to recommend approval of an Oceana Therapeutics PMA for Solesta, a bulking ...

Reviewers Raise Safety Concerns on Orexigen Weight-loss NDA

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FDA reviewers say there are cardiovascular safety concerns associated with the potential approval of Orexigen's proposed weight-lo...

Comments Sought on Indexing Unapproved Animal Drugs

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Federal Register Notice; FDA seeks comments on indexing legally marketed unapproved new animal drugs for minor species.

Comments Sought on Indexing Approved Animal Drugs

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Federal Register Notice: FDA seeks comments on indexing legally marketed new animal drugs for minor species.

Info on Clinical Efficacy in Labeling Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on a study of clinical efficacy information in professiona...

Q&A Guidance on Residual Solvents in Animal Drugs

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Federal Register Notice: FDA releases a draft guidance answering questions on CVMs implementation of USP residual solvents in anim...