FDA Related News

Federal Register

Regulatory Review Determinations on 8 NDAs

Federal Register notices: FDA publishes notices about the regulatory review period determinations for eight drug products sponsored by KemPharm, Apell...

Human Drugs

Karuna NDA for Schizophrenia Accepted by FDA

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

Praise for Graft-Versus-Host Drug Guidance

Stakeholders comment positively on an FDA draft guidance on developing products to prevent or treat graft-versus-host disease.

Human Drugs

FDA Studies Nasal Spray Distribution

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

Medical Devices

Vivos Sleep Apnea Device Cleared

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

Medical Devices

FDA Still Evaluating Left Atrial Occlusion Implants

FDA continues to evaluate information about the potential for differences in procedural outcomes between women and men undergoing implant of a left at...

New Theories of False Claims Act Liability

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

Medical Devices

AdvaMed Comments on Electronic Submission Guide

AdvaMed raises concerns about an FDA draft guidance on De Novo electronic submissions.

Human Drugs

Concerns About FDA QMM Program

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

Marketing

Durbin, Grassley Push Drug Ad Transparency Bill

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