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Most Post-Approval Studies On Track: Stein

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CDER Office of New Drugs deputy director Peter Stein says the backlog of post-marketing requirements and commitments has been dras...

Opinions Vary on Pre-DSHEA Supplement List

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Stakeholders suggest ways FDA can develop a list of pre-DSHEA dietary supplement ingredients or express concern that building such...

FDA Clears Camber Spine Interbody Fusion Implant

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FDA clears a Camber Spine 510(k) for the SPIRA-C Open Matrix Cervical Interbody device, an interbody fusion implant.

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FDA issues a draft guidance to help sponsors use a possible new approach to developing drugs to treat pediatric rare diseases.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