FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1

2023 Trial Diversity Workshop Report

FDA publishes its report on an 11/2023 workshop on increasing clinical trial diversity.

latest-news-card-1
Federal Register

Guide on ANDA Facility Inspection Readiness

Federal Register notice: FDA makes available a final guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA.

latest-news-card-1
Federal Register

Animal Drug User Fee Educational Conference

Federal Register notice: FDA announces a 7/17 educational conference (public meeting) entitled First Annual Animal Drug User Fee Educational Conferenc...

latest-news-card-1
Medical Devices

Former Device Company CEO Gets 6 Years in Prison

A New York federal judge orders Stimwave founder and former CEO Laura Perryman to serve six years in jail for medical device healthcare fraud.

latest-news-card-1
Medical Devices

FDA Asks Input on Non-Device Software Functions, Impacts

FDA asks for input on certain non-device software functions and impacts on patient safety.

latest-news-card-1
Human Drugs

Protein Data Bank Aided 100% of Targeted Cancer Drugs: Study

Academic researchers say all 34 low molecular weight, protein-targeted, antineoplastic agents approved by FDA between 2019 and 2023 were facilitated i...

latest-news-card-1
Human Drugs

Truqap Misses Endpoints in Breast Cancer Trial

AstraZeneca says its CAPItello-290 Phase 3 trial of Truqap (capivasertib) in combination with paclitaxel in patients with locally advanced or metastat...

latest-news-card-1
FDA General

FDA WEBVIEW CLOSED 6/19 FOR JUNETEENTH

FDA Webviews newsroom closes Wednesday 6/19 in recognition of the federal holiday Juneteenth.

latest-news-card-1
Federal Register

Medical Gas GMP, Safety Reporting Rule

Federal Register notice: FDA issues a final rule revising its requirements for current good manufacturing practice, postmarketing safety reporting, an...

latest-news-card-1
Human Drugs

Clinical Hold on Zentalis Drug After 2 Deaths

FDA places a partial clinical hold on three Zentalis Pharmaceuticals azenosertib studies after two recent deaths due to presumed sepsis were reported....