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Guide on Quality Risk Management

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Federal Register notice: FDA makes available a final guidance entitled Q9(R1) Quality Risk Management.

15 Info Collections Approved by OMB

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Federal Register notice: FDA posts a list of 15 information collections that have been recently approved by OMB.

Fibrogen Misses Endpoint in Roxadustat Anemia Trial

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A FibroGen Phase 3 study of its anemia drug roxadustat fails to meet its primary efficacy endpoint.

FDA Issues Ajinomoto Bio-Pharma 3-item 483

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FDA issues Ajinomoto Bio-Pharma Services a three-item Form FDA-483 after inspecting the firm in January.

PhRMA, Others Petition Against Drug Importation

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A citizen petition from PhRMA and other groups urges FDA to not approve a proposal from Colorados Department of Health Care Policy...

Actual Use Study Flagged in OTC Birth Control NDA

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FDA reviewers question the reliability of an actual use study that was submitted to support approval of a Laboratoire HRA Pharma N...

FDA Reviewing Glaukos NDA for Glaucoma

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FDA accepts for review a Glaukos NDA for iDose TR (travoprost intraocular implant) for treating open-angle glaucoma or ocular hype...

Levitra Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Bayers Levitra (vardenafil HCl) oral tablets (5mg, 10mg and 20mg) were not withdrawn ...

Guide on Decentralized Clinical Trials

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Federal Register notice: FDA makes available a draft guidance entitled Decentralized Clinical Trials (DCT) for Drugs, Biological P...

Reject Rexulti Alzheimers sNDA: Public Citizen

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Alleging weak evidence of effectiveness accepted by an advisory committee, Public Citizen calls on FDA to reject an Otsuka/Lundbec...