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AstraZeneca Covid-19 Trial Stops Over Safety Signal

[ Price : $8.95]

An AstraZeneca and University of Oxford Phase 3 vaccine study stalls as a clinical hold is issued due to a serious adverse reactio...

Guidance on Pharmacokinetics in Patients with Impaired Renal Function

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Pharmacokinetics in Patients with Impaired Renal Function ...

Info Collection on Device Allegations Submitted to CDRH

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Federal Register notice: FDA sends to OMB an information collection extension for Electronic Submission Process for Voluntary Alle...

Joint Panel to Review ADHD Drug

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Federal Register notice: FDA announces a 10/8 joint advisory committee meeting to review an Arbor Pharmaceuticals NDA for a drug t...

Priority Review Voucher Awarded on Viltepso OK

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Federal Register notice: FDA issues Nippon Shinyaku a priority review voucher after approval of its rare disease drug Viltepso (vi...

Biological Evaluation of Medical Devices Guidance

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FDA posts a final guidance entitled Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: E...

Ascendis Pharma BLA for Growth Hormone Deficiency

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FDA accepts an Ascendis Pharma BLA for its TransCon hGH (lonapegsomatropin), an investigational long-acting prodrug of somatropin ...

Orphan Status for Project ALS Drug

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FDA grants Project ALS an orphan drug designation for prosetin and its use in treating amyotrophic lateral sclerosis.

Panel to Review Refocus Vision Implant

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Federal Register notice: FDA announces an 11/9 device panel meeting that will review a Refocus Group PMA for the VisAbility Micro ...

Guide on Controlling Nitrosamine Impurities

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Control of Nitrosamine Impurities in Human Drugs.