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Mixed State Court Decision in Tenofovir Case

[ Price : $8.95]

A California appeals court affirms in part and reverses in part a trial court decision in a case involving negligence claims again...

Revised GDUFA Request for Reconsideration Guide

[ Price : $8.95]

FDA publishes a draft guidance on requesting reconsideration of ANDA decisions to reflect the current GDUFA reauthorization.

CTTI Sees Barriers to Trial Reporting

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In a project conducted with FDA, the Clinical Trials Transformation Institute identifies barriers to timely and complete reporting...

Guide on Sterility Info in 510(k) Submissions

[ Price : $8.95]

FDA revises its guidance entitled Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions fo...

Alcons Positive Dry Eye Phase 3 Trials

[ Price : $8.95]

Alcon announces positive topline results from two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) evaluating the efficacy an...

Priority Review Voucher for Adzynma Approval

[ Price : $8.95]

Federal Register notice: FDA announces the issuance of a priority review voucher to Takeda Pharmaceuticals for its qualified rare ...

Priority Voucher Awarded to Amryt Pharma

[ Price : $8.95]

Federal Register notice: FDA announces the issuance of a priority review voucher to Amryt Pharmaceuticals for its qualified rare p...

Sellas Life Sciences Gets Fast Track

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FDA grants Sellas Life Sciences a fast track designation for SLS009, a highly selective CDK9 inhibitor for treating relapsed/refra...

Searchable FDA Pharmaceutical Quality Repository

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FDA launches a new search function on its Office of Pharmaceutical Quality Web page to improve access to drug quality resources.

CRL for Astellas Zolbetuximab BLA

[ Price : $8.95]

FDA says it cant approve Astellas zolbetuximab BLA by the 1/12 PDUFA action date due to unresolved issues at a third-party manufac...