FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Information Technology Operating Plan Posted

[ Price : $8.95]

The FDA Office of Digital Transformation posts its new IT operating plan and its 2023 annual report.

FDA Approves Ipsens Pancreatic Cancer Drug

[ Price : $8.95]

FDA approves an Ipsen Biopharmaceuticals NDA for Onivyde (irinotecan liposome) for use in combination with oxaliplatin, fluorourac...

5-Year Debarment for Ross Lucien

[ Price : $8.95]

Federal Register notice: FDA issues an order debarring Ross Lucien for five years from importing any drug into the U.S.

Kalpen Patel Debarred by FDA

[ Price : $8.95]

Federal Register notice: FDA issues an order to permanently debar Kalpen D. Patel from providing services in any capacity to a per...

Data Monitoring Draft Guidance Released

[ Price : $8.95]

Federal Register notice: FDA releases a draft guidance entitled Use of Data Monitoring Committees in Clinical Trials.

FDA Warns 2 Firms Over Illegal Weight-Loss Drugs

[ Price : $8.95]

FDA warns Miami, FL-based US Chem Labs and Bronx, NY-based Helix Chemical that they are selling unapproved and misbranded versions...

ICH Draft Guide on Post-Approval Safety Data

[ Price : $8.95]

FDA publishes an ICH draft guideline on post-approval safety data that is available for comment.

Nanox Fatty Liver Detector Cleared by FDA

[ Price : $8.95]

FDA clears a Nanox AI 510(k) for HealthFLD, an artificial intelligence software that provides automated qualitative and quantitati...

FDA Getting Stricter on Cybersecurity Enforcement

[ Price : $8.95]

Former FDAer Naomi Schwartz says medical device companies must prioritize cybersecurity compliance to meet a stricter FDA enforcem...

FDA Issues Data Monitoring Committee Draft Guide

[ Price : $8.95]

FDA makes available a draft guidance entitled Use of Data Monitoring Committees in Clinical Trials.