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Avadel Sues FDA Over Lumryz NDA Delay

[ Price : $8.95]

Avadel sues FDA over the agencys decision to require a patent statement for the companys Lumryz NDA.

Develop Regulatory Framework for Synthetic Cells: Paper

[ Price : $8.95]

A Stat News opinion column argues the need for FDA and those working on synthetic cell therapies to open talks on an appropriate r...

FDA Accepts Biogen Tofersen NDA for Rare ALS

[ Price : $8.95]

FDA accepts a Biogen NDA for tofersen to treat a rare form of ALS and grants it priority review.

FDA Grants Taiho Oncology Lonsurf Petition

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FDA grants a Taiho petition restricting generic forms of its Lonsurf cancer drug.

Many Supplements Stay on Market After FDA Warning

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Researchers say FDA needs to strengthen enforcement against dietary supplements that contain prohibited ingredients.

Northeast Scientific 510(k) for Reprocessing Laser Catheter

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FDA clears a Northeast Scientific 510(k) for reprocessing Philips Spectranetics 0.9mm OTW Turbo-Elite laser atherectomy catheter, ...

Biotronik Pulsar-18 T3 Stent Approved

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FDA approves a Biotronik PMA for its Pulsar-18 T3 peripheral self-expanding stent system that is intended to improve implantation ...

Antibacterial Therapy Guidance Comments

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Two drug companies comment on an FDA draft guidance on antibacterial therapies.

Orange Book Questions & Answers Guide

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Federal Register notice: FDA makes available a final guidance entitled Orange Book Questions and Answers.

ANDA Complete Response Letter Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Failure To Respond to an ANDA Complete Response Letter With...