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ANDA Approval Allowed After Draft Labeling Review: FDA

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FDA says it will speed up generic drug approvals by allowing marketing on the basis of submitted draft, rather than final printed ...

FDA Warning Letter to St. Jude Medical

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FDA issues St. Jude Medical a Warning Letter citing its Atlantia, GA manufacturing facility for GMP violations related to the manu...

Comments Sought on Xenotransplantation Guideline

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Federal Register Notice: FDA seeks comments on a proposed collection of information in the Public Health Service guideline on xeno...

Comments Sought on Abuse Potential of 10 Drug Substances

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Federal Register Notice: FDA requests comments on the abuse potential, etc. of 10 drug substances to prepare a response to the Wor...

FDA Alert on Bioprosthetic Aortic Valve Motion

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FDA says it has received recent reports about the reduced leaflet motion in some bioprosthetic aortic valves, including both trans...

FDA Orders Duodenoscope Postmarket Surveillance Studies

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FDA orders the three makers of duodenoscopes to conduct postmarket surveillance studies to better understand how the devices are r...

FTC Weighs in on Brand Drug Product Hopping

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An FTC brief to the Third Circuit Court of Appeals calls into question brand name drug makers product-hopping, whereby companies m...

Sandoz Files 2nd Biosimilar App for Amgen Drug

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FDA accepts a Sandoz BLA (351(k) pathway) for a proposed biosimilar to Amgens Enbrel (etanercept), indicated for treating a range ...

Merck Gains Accelerated Approval for Keytruda in Lung Cancer

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FDA grants Merck accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lun...

510(k) Blues: Morcellator Activist Calls for Shurens Resignation

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Philadelphia cardiothoracic surgeon Hooman Norchashm meets with CDRH director Jeffrey Shuren and calls for his resignation over hi...