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Regulatory Review Determinations on 8 NDAs

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Federal Register notices: FDA publishes notices about the regulatory review period determinations for eight drug products sponsore...

Karuna NDA for Schizophrenia Accepted by FDA

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FDA accepts for review a Karuna Therapeutics NDA for KarXT (xanomeline-trospium) for treating schizophrenia in adults.

Praise for Graft-Versus-Host Drug Guidance

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Stakeholders comment positively on an FDA draft guidance on developing products to prevent or treat graft-versus-host disease.

FDA Studies Nasal Spray Distribution

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A CDER study examines generic nasal spray distribution factors that could speed the development of generic sprays.

Vivos Sleep Apnea Device Cleared

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FDA clears a Vivos Therapeutics 510(k) for its Vivos CARE (Complete Airway Repositioning and/or Expansion) appliances for treating...

FDA Still Evaluating Left Atrial Occlusion Implants

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FDA continues to evaluate information about the potential for differences in procedural outcomes between women and men undergoing ...

New Theories of False Claims Act Liability

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A lengthy online newsletter written by several Skadden attorneys explores possible new theories of cybersecurity False Claims Act ...

AdvaMed Comments on Electronic Submission Guide

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AdvaMed raises concerns about an FDA draft guidance on De Novo electronic submissions.

Concerns About FDA QMM Program

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The Association for Accessible Medicines raises several issues and concerns with FDAs proposal to develop a quality management mat...

Durbin, Grassley Push Drug Ad Transparency Bill

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Sen. Mike Crapo blocks an attempt by Sens. Dick Durbin and Charles Grassley to get unanimous consent to approve their bipartisan d...