FDA Related News

Medical Devices

Vivos Gets Sleep Apnea Device Cleared

FDA clears a Vivos Therapeutics 510(k) for its daytime-nighttime appliance for treating obstructive sleep apnea and snoring in adults.

Human Drugs

Consider Oncology Single-Arm Trial Issues: CDER

CDER researchers discuss some of the challenges in using single-arm trials to support the approval of oncology drugs.

Human Drugs

FDA Lifts Partial Hold on Bluebird Bio Lovo-Cel Study

Bluebird Bio says it is working to resume enrollment and treatment of patients ages 2-17 in a lovo-cel sickle cell clinical trial after FDA lifts a pa...

FTC Updates Health Products Compliance Guide

Attorney Phyllis Marcus says an updated Federal Trade Commission compliance guidance covers dietary supplements and adds many additional health-relate...

Human Drugs

CGMP Deviations Found at MD Pharmaceutical Supply

FDA warns Hanover, PA-based MD Pharmaceutical Supply about CGMP deviations in its drug repackaging and relabeling operations.

Human Drugs

CGMP Deviations at Brazils Nortec Quimica

FDA warns Brazils Nortec Quimica about CGMP deviations in its production of active pharmaceutical ingredients.

Human Drugs

FDA States Plan B One-Step Does Not Cause an Abortion

FDA revises the Plan B One-Step information sheet to clarify the emergency contraceptive cannot be used to cause an abortion of an existing pregnancy.

Human Drugs

Court Enters Consent Decree Against Oklahoma Compounder

An Oklahoma federal court issues a consent decree against the Qualgen drug compounding facility and two of its principals.

Medical Devices

Spending Bill Reverses Some FDA Court Losses: Attorneys

Two Hyman, Phelps & McNamara attorneys say FDA succeeded in having Congress use the recent omnibus spending bill to allow it to ban some individual us...

Human Drugs

FDA Pushing Naloxone OTC Switch: Attorney

Attorney Heidi Gertner explains how FDA is pushing for a voluntary Rx to OTC switch of naloxone drug products.