FDA Related News

Medical Devices

False Results in Some Prenatal Screening Tests

FDA cautions that noninvasive prenatal screening tests can give false results that can lead to inappropriate decisions without a confirmatory diagnost...

Human Drugs

PI3K Briefing Document Reiterates FDA Concerns

FDA reiterates concerns with phosphatidylinositol 3-kinase (PI3K) inhibitors and their approval for treating hematological malignancies.

Human Drugs

Center for Rare Neurological Diseases Warned on 2 Trials

FDA warns the Norcross, GA-based Center for Rare Neurological Diseases about human subject protection violations in its conduct of two clinical trials...

Federal Register

Published Literature Used for Animal Drugs Guide

Federal Register notice: FDA makes available a draft guidance for industry #106 entitled The Use of Published Literature in Support of New Animal Drug...

Federal Register

FDA Corrects ANDA Withdrawal Notice

Federal Register notice: FDA corrects a 2/28 notice announcing the withdrawal of approval of five ANDAs from multiple applicants.

Human Drugs

CGMP Violations at Vi-Jon Facility

FDA warns St. Louis, MO-based Vi-Jon about CGMP violations in its production of finished drugs.

Federal Register

FDA Debars Clinical Investigator

Federal Register notice: FDA permanently debars Yvelice Villaman-Bencosme from providing services in any capacity to a person that has an approved or ...

Federal Register

FDA Revokes 5 Covid Test EUAs

Federal Register notice: FDA is revoking the emergency use authorizations on five no-longer-marketed Covid-19 tests.

Human Drugs

Pazdur et al Weigh Challenges with PI3K Inhibitors

Writing in an online Lancet Oncology article, FDA officials outline challenges with current PI3K inhibitors that have the agency reconsidering how the...

Diversity Plans Needed Before Phase 3: Law Firm

A Hogan Lovells analysis of FDAs recent guidance on clinical trial diversity plans says such plans should be an important part of drug and device deve...