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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.

CDRH Guidance Document Listing

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Federal Register notice: FDA announces the Web site location where it will post two lists of guidance documents that CDRH intends ...

Guidance on Drug Name Placement/Prominence in Ads

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Federal Register notice: FDA makes available a guidance entitled Product Name Placement, Size, and Prominence in Promotional Label...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Fagron Compounding Services, RC Outsourcing and Seindni Co.

Comments Sought on FDA Fellowship Program Apps

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Federal Register notice: FDA seeks comments on an information collection extension for FDA Application for Participation in FDA Fe...

Name Placement in Drug Ads Final Guidance

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FDA posts a final guidance on Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements for drugs. ...

Janssen Files sNDA for Xarelto Cardiovascular Benefits

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Janssen Research & Development submits a supplemental NDA for two new Xarelto (rivaroxaban) vascular indications: reducing the ris...