FDA Related News

Federal Register

Info Collection on Combination Product Jurisdiction

Federal Register notice: FDA sends to OMB an information collection extension entitled Product Jurisdiction and Combination Products 21 CFR Parts 3 a...

Human Drugs

UCB on Pregnancy Safety Studies

UCB makes suggestions for FDA to consider in developing a framework to optimize post-approval pregnancy safety studies.

Medical Devices

FDA Clears GE Critical Care Suite 2.1

FDA clears GE Healthcares Critical Care Suite 2.1 that includes a pneumothorax algorithm.

Human Drugs

Arcturus Therapeutics Orphan Status for ARCT-032

FDA grants Arcturus Therapeutics an orphan drug designation for ARCT-032 and its use to treat cystic fibrosis.

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Stakeholders comment positively on an FDA draft guidance on developing products to prevent or treat graft-versus-host disease.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