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FDA Accepts Fennec Pedmark NDA Resubmission

[ Price : $8.95]

FDA accepts for filing the resubmission of a Fennec Pharmaceuticals NDA for Pedmark.

CoreLink Vertebral Body Replacement Device Cleared

[ Price : $8.95]

FDA clears a CoreLink 510(k) for the F3D Corpectomy VBR System, a vertebral body replacement that is intended to surgically replac...

FDA Extends Comment Deadline for Device Info Discussion Paper

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FDA extends the comment deadline for a discussion paper on how medical device materials information could be communicated.

Consider Exploring EOP2 Loophole: Attorney

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Attorney Josephine Torrente says drug sponsors disagreeing with FDA over a Phase 3 protocol have no right of appeal and could cons...

Firm Selling Misbranded, Unapproved New Drugs: FDA

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FDA warns Molecular BioLife it is marketing misbranded unapproved new drugs via a Web site.

Ex-FDA Chief Counsel Joins Morrison & Foerster

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Former FDA chief counsel Stacy Cline Amin joins Morrison & Foerster as a partner in its life sciences/healthcare practice.

Agios Pharma NDA for Pyruvate Kinase Deficiency

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Agios Pharmaceuticals files an NDA for mitapivat for treating adults with pyruvate kinase deficiency.

Review of Drug Trials with External Controls

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Researchers say FDA guidance on external controls in drug trials should be revised to reflect the use of retrospective natural his...

Gilead Reports Promising Veklury Mortality Data

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Gilead Sciences reports favorable mortality risk reductions for its Veklury (remdesivir) in hospitalized Covid-19 patients.

Guide on Reporting CMC Changes for BLAs

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FDA posts a final guidance on chemistry, manufacturing, and controls changes to an approved BLA.