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Consent Decree with Two Tennessee Companies

[ Price : $8.95]

FDA says a Tennessee federal judge entered a consent decree against two companies to prohibit them from distributing drugs, dietar...

FDA Warns Umbilical Cord Blood Firm

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FDA warns Stemell about multiple violations in its production of umbilical cord and umbilical cord blood products.

Review Period Determined for Bevyxxa

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Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Millennium Pharmaceuticals ...

CDERs Temple Covers Individualization in Drug Development

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CDER deputy center director for clinical science Robert Temple discusses the move by industry and the agency to the third age of d...

Comments Extension for MRI-safe Device Guide

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Federal Register notice: FDA extends the comment period for an 8/2 notice on a draft guidance on testing and labeling medical devi...

CGMP Deviations at Chinas Yino, Inc.

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FDA warns Chinas Yino, Inc., about significant CGMP deviations in its manufacturing of APIs.

7 REMS Updates in July, August

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FDA releases a summary of changes to seven REMS shown on the REMS Web site in July and August.

Novartis Plans BLA for Arzerra in MS

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Novartis says it will file a BLA and seek other global approvals for its leukemia drug Arzerra (ofatumumab) and its use in treatin...

CDRH Seeks to Fill Vacancies on Device Panels

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Federal Register notice: FDA requests nominations for voting members to serve on CDRHs Device Good Manufacturing Practice Advisory...

Docket No. on Pediatric Rare Disease Corrected

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Federal Register notice: FDA corrects the docket number in a 12/2017 notice entitled Pediatric Rare Diseases--A Collaborative Appr...