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Panel to Tackle Pulse Oximeter Quality

[ Price : $8.95]

Federal Register notice: FDA announces a 2/2/2024 advisory committee meeting to discuss pulse oximeter quality.

Device Discontinuance and 506J List Guidances

[ Price : $8.95]

FDA issues one final and one draft guidance related to Section 506J notifications of medical device shortages.

FDA Publishes 40 Product-Specific Guidances

[ Price : $8.95]

FDA publishes 22 new and 18 revised product-specific guidances for developing generic drugs.

Device Computational Modeling Credibility Guide

[ Price : $8.95]

FDA publishes a guidance to help in assessing the credibility of computational modeling and simulation in medical device submissio...

U.S. Drug Shortages Increasing: Report

[ Price : $8.95]

An Iqvia Institute report says drug shortages continue to increase in the U.S., with the number of new shortages outpacing the num...

Provide Covid Therapeutics Distribution Info: Califf

[ Price : $8.95]

FDA commissioner Robert Califf calls on the Healthcare Distribution Alliance to give aggregate information to the agency on the di...

2 Consent Decrees Against Supplement Marketers

[ Price : $8.95]

The central Utah federal court approves two consent decrees of permanent injunction against Evig LLC and Premium Production LLC ov...

SpringWorks Filing Mirdametinib NDA in 2024

[ Price : $8.95]

After releasing promising clinical data, SpringWorks Therapeutics says it will file an NDA in the first half of 2024 for mirdameti...

Janet Woodcock Retiring in Early 2024

[ Price : $8.95]

FDA principal deputy commissioner Janet Woodcock announces she is retiring early next year after 37 years at the agency.

Managing Legacy Device Cyber Risks

[ Price : $8.95]

An FDA-funded report makes recommendations for improving the cybersecurity of legacy medical devices.