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Noroxin Not Withdrawn Due to Safety/Effectiveness: FDA

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Federal Register notice: FDA determines that Mercks Noroxin (norfloxacin) tablets, 400 mg, was not withdrawn due to safety or effe...

FDA Deceptive Ad Recognition Research Advancing

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FDA asks the Office of Management and Budget to review its proposal for two studies determining how well consumers and healthcare ...

CGMP, Labeling Violations at Koreas Seindni Company

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FDA warns Koreas Seindni Company about CGMP and labeling violations in its manufacturing of finished drug products.

FDA Drug Product Gluten Recommendations

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FDA releases a draft guidance with recommendations on how to include information on gluten content in certain drug products.

Number of Early Feasibility IDEs More Than Double

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CDRH staffers say the number of IDEs submitted for early feasibility studies has more than doubled in the second year of the progr...

NDA, BLA Refuse-to-File Guidance

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FDA issues a draft guidance explaining some circumstances under which the agency may refuse to file a new or supplemental NDA or B...

FDA Approves Expanded Use for Glaxos Nucala

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FDA expands the approved use of GlaxoSmithKlines Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis wit...

Comments Sought on Orphan Drug Request Information Collection

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Federal Register notice: FDA seeks comments on an information collection extension for Orphan Products Development; FDA Orphan Dru...

CDRH Working to Improve Patient-Reported Outcomes

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CDRH outlines steps it is taking to improve and expand use of patient-reported outcomes in regulatory proceedings.

AdvaMed Recommends Appraisal Program Improvements

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AdvaMed recommends ways to improve CDRHs voluntary medical device manufacturing and product quality program.