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FDA Warns 2 Firms on Human Cells/Tissues

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FDA warns New Hope Center for Reproductive Medicine and Regenerative Labs about violations involving human cells, tissue, and cell...

Most Common 2022 BIMO Violations

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Three Goodwin attorneys analyze the results of BIMO inspections in 2022 and the beginning of 2023, listing most common violations....

Consumer Groups Sought for Advisory Panels

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Federal Register notice: FDA asks that consumer organizations notify the agency if they are interested in participating in selecti...

Guide on Metabolism Inborn Errors

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Federal Register notice: FDA makes available a revised draft guidance entitled Inborn Errors of Metabolism That Use Dietary Manage...

BeiGene sNDA for Brukinsa in Lymphoma

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FDA accepts a BeiGene supplemental NDA for Brukinsa (zanubrutinib) in combination with obinutuzumab for treating adult patients wi...

Panel to Discuss Decongestant Phenylephrine

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Federal Register notice: FDA announces a 9/11-12 Nonprescription Drugs Advisory Committee meeting to discuss decongestant phenylep...

Lymphoma Trial Enrollment Paused After 7 Deaths

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ADC Therapeutics pauses new patient enrollment in the Phase 2 LOTIS-9 clinical trial evaluating Zynlonta (loncastuximab tesirine-l...

Praise for FDA Final PFDD Guidance

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Three stakeholders praise an FDA guidance on adding clinical outcome assessments to patient-focused drug development regulatory de...

Megadyne Recalls MEGA Patient Electrodes

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Megadyne recalls its MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes after receiving burn reports affecting pediatric a...

Innovative Manufacturing Workshop Positive Comments

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Two stakeholders respond positively to a recent FDA workshop on innovative drug manufacturing techniques.