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FDA Approves Sunovion NDA for COPD Drug

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FDA approves a Sunovion Pharmaceuticals NDA for Lonhala Magnair (glycopyrrolate) inhalation solution (25 mcg twice daily) for the ...

Senator Manchin Seeks 3 Opioid Policy Changes

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Senator Joe Manchin (D-WV) calls on FDA to adopt three policy changes through its Opioid Policy Steering Committee to reduce unnec...

Antimicrobial Sales Down Last Year: CVM Report

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A CVM report shows a decrease in antimicrobials sales from 2015 through 2016.

FDA Issues Rare Pediatric Disease Guidance

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FDA issues a draft guidance to help sponsors use a possible new approach to developing drugs to treat pediatric rare diseases.

Glenmark Pharmaceuticals FDA-483 Released

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FDA releases a FDA-483 with seven observations from an inspection at Indias Glenmark Pharmaceuticals.

FDA Approves Novo Nordisk Diabetes Therapy

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FDA approves a Novo Nordisk NDA for Ozempic (semaglutide) injection 0.5 mg and 1 mg, a once-weekly glucagon-like peptide receptor ...

Guide on Serological Tests to Reduce T. Cruzi Infections

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Federal Register notice: FDA makes available a guidance entitled Use of Serological Tests to Reduce the Risk of Transmission of Tr...

Key Changes in Final UDI Guidance

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CDRH UDI regulatory policy analyst Christina Savasaar says two key changes were made between draft and final guidances on UDI dire...

Group Petitions FDA to Ban Cesium Chloride from Compounding

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Advocacy group Public Citizen petitions FDA to add cesium chloride to its 503A Category 2 list of bulk drug substances identified ...

FDA Unveils Predictive Toxicology Roadmap

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Two FDAers say the agency has issued a Predictive Toxicology Roadmap and will hold a public workshop to help foster opportunities ...