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Class 3 for Certain Wound Dressings

[ Price : $8.95]

Federal Register notice: In separate rulemakings, FDA proposes to classify into Class 3 certain types of wound dressings and liqui...

FDA Fast Track for eFFECTORs Zotatifin

[ Price : $8.95]

FDA grants fast-track designation to eFFECTOR Therapeutics for its zotatifin in combination with two other drugs as a second- or t...

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

[ Price : $8.95]

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Stakeholders comment positively on an FDA draft guidance on developing products to prevent or treat graft-versus-host disease.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

[ Price : $8.95]

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 ...

FDA Opens Drug Supply Chain Security Act Portal

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FDA launches a Drug Supply Chain Security Portal as part of the CDER Next Gen Portal.