FDA Related News

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Stakeholders comment positively on an FDA draft guidance on developing products to prevent or treat graft-versus-host disease.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

Human Drugs

FDA Opens Drug Supply Chain Security Act Portal

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

Human Drugs

FDA Denies Apixaban ANDA Petition for Safety

FDA denies for reasons of safety a 2017 petition seeking approval to submit an ANDA for a generic form of Bristol-Myers Squibbs Eliquis with a higher ...

Human Drugs

SCA Pharma Issued 10-Item FDA-483

FDA posts a 10-item Form FDA-483 related to an inspection last month at SCA Pharmaceuticals Windsor, CT outsourcing facility.

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AdvaMed raises concerns about an FDA draft guidance on De Novo electronic submissions.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