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Comments Sought on ANDA Submissions Guide

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Federal Register notice: FDA establishes a docket to solicit comments on the content of Appendix A in the 7/2018 guidance for indu...

New Drug Launch Prices This Year Jump 43%: Analysis

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A new drug pricing analysis finds that for drugs launched so far this year, their median pricing ($257,000) is 43% more than the m...

Emergent BioSolutions Hit with FDA Warning Letter

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FDA issues Emergent BioSolutions an 8/10 Warning Letter after a February inspection cites GMP issues at its Camden, MD manufacturi...

Pharma CEO Pleads Guilty to FDA False Statements

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French national and Hexim Pharmaceuticals chief executive officer Alain Bouaziz pleads guilty to making false statements to FDA to...

Gilead Sciences sBLA for Trodelvy

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Gilead Sciences files a sBLA for Trodelvy (sacituzumab govitecan-hziy), seeking expanded approval in patients with HR+/HER2- metas...

Medtronic Recalls Cobalt & Crome Defibrillators

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Medtronic recalls its Cobalt and Crome implantable cardioverter defibrillators because the devices have the potential for reduced ...

Dyad Medical AI Echocardiogram App Cleared

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FDA clears a Dyad Medical 510(k) for its echocardiogram application called Echo:Prio.

2 Children Die After Taking Novartis Gene Therapy

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Weeks after being administered a Novartis gene therapy, two children die of acute liver failure, according to the company.

Info Collection on Device Sterilization Agreements

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Federal Register notice: FDA sends to OMB an information collection extension entitled Agreement for Shipment of Devices for Steri...

9 ICH Vet Med Guidances Published

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FDA posts nine guidances released by the International Cooperation on Harmonization of Technical Requirements for Registration of ...