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FDA Accepts Eisai NDA for Treating Thyroid Cancer

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FDA accepts for priority review an Eisai NDA for its in-house developed anticancer agent lenvatinib mesylate as a treatment for pr...

Comments Sought on Condom Labeling

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Federal Register Notice: FDA seeks comments on an information collection on the labeling of natural rubber latex condoms.

Guidance on Device Recalls vs. Enhancements

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Federal Register Notice: FDA releases a guidance on distinguishing device recalls from medical device enhancements.

FDA Approves 2 NDAs for Idiopathic Pulmonary Fibrosis

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FDA approves two NDAs ahead of their user fee goal dates for treating idiopathic pulmonary fibrosis.

NCTR Studying Pediatric Brain Function

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FDA National Center for Toxicological Research scientists say they have spent 25 years studying the effects of drugs on childrens ...

Dietary Supplement Firms Dont Know GMP: Consultant

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Dietary supplement GMP consultant Rick Soltero says companies are starting to understand that being GMP-compliant is a marketing c...

Ex-FDA Generic Official Pollock Moves to Melbourne Labs

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Newly-created Melbourne Laboratories names former CDER Office of Generic Drugs acting deputy director Robert W. Pollock as its fou...

8 New, Updated REMS

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FDA identifies one new and seven updated REMS for drugs.

ISPE Drug Shortage Prevention Plan Out

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ISPE releases its drug shortage prevention plan calling for a holistic approach to avoiding drug shortages and maintain a robust m...

Comments Sought on Generic Drug Appearance Changes

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Federal Register Notice: FDA seeks comments on a survey of pharmacists and patients on their experiences resulting from changes in...