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Did FDA Lose Leverage in Approving Ranbaxy Generic Lipitor?

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FDA and federal prosecutors seem to have passed up a huge leverage opportunity to win a settlement and resolve outstanding issues ...

Dietary Supplement Firms and Owners Sentenced for Contempt

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A New Jersey federal judge gives three men jail time for violating a consent decree to close their dietary supplement manufacturin...

NPS Finishes Gattex NDA Submission

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NPS Pharmaceuticals says it has completed submitting a Gattex NDA and has asked FDA for a priority review.

Blanket Malfunction Reporting for Life-supporting Devices

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CDRH confirms that any device malfunction, regardless its severity, is a reportable event under FDAs Medical Device Reporting regu...

Artificial Pancreas System Guidance Out

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FDA issues a guidance to help manufacturers and researchers understand the minimum requirements the agency thinks must be met for ...

Co-crystal Regulatory Classification Guidance Out

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FDA issues a draft guidance giving CDERs current thinking on the appropriate classification of co-crystal solid state forms and th...

FDA Gives Emergent Leukemia Drug Orphan Status

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FDA grants orphan drug designation for Emergent BioSolutions TRU-016 to treat chronic lymphocytic leukemia.

Ben Venue Closes Ohio Facility

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FDA says Ben Venue has closed its Bedford, OH, manufacturing and distribution facility and is working with the agency to ease a sh...

FDA Clears Covidiens SpiderFX for Calcified Lesions in Arteries

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FDA clears a Covidien 510(k) for the SpiderFX for treating severely calcified lesions in arteries of the lower extremities.

Mylan, Famy Care Sued Over Generic Generess

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Mylan says it and Famy Care Ltd. have been sued by Warner Chilcott after recentyly submitting an ANDA for a generic version of the...