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CDRH Cover-up on Device Classification Form Changes: Petitioner

[ Price : $8.95]

CDRH comes under fire after quietly revising its Classification Questionnaire (Form FDA 3429) based on a citizen petition that que...

Dara BioSciences Seeks Orphan Status for Chemo Pain Drug

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Dara BioSciences files an Orphan Drug Application for KRN5500, a compound in development to treat a painful form of chronic chemot...

FDA Approves Mylans Generic Detrol

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FDA approves a Mylan ANDA for tolterodine tartrate tablets (1mg and 2mg), a generic version of Pharmacia and Upjohns Detrol.

Comments Sought on Biologics Constituent Materials

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Federal Register Notice: FDA seeks comments on a proposed collection of information on the use of constituent material in biologic...

Panel to Discuss Shortwave Diathermy Device Reclassification

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Federal Register Notice: FDAs Orthopedic and Rehabilitation will meet 4/5/13 to discuss the possible reclassification to Class 3 o...

Guidance on Preclinical Cellular and Gene Therapy Info

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Federal Register Notice: FDA releases a draft guidance on preclinical assessment of investigational cellular and gene therapy prod...

Upton to Lead Energy and Commerce Again

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House Energy and Commerce Committee chair Fred Upton announces subcommittee chairs and vice chairs.

FDA Clears NeuroMetrix Pain Nerve Stimulator

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FDA clears a NeuroMetrix 510(k) for a disposable electrode that is used in conjunction with its SENSUS device, a transcutaneous el...

FDA Approves Cometriq for Thyroid Cancer

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FDA approves Exelixis Cometriq for treating metastatic thyroid cancer.

Ranbaxy Stops Generic Lipitor Pending Recall Probe

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FDA says Ranbaxy has stopped manufacturing generic Lipitor (atorvastatin) until it has resolved an earlier reported recall problem...