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De Novo OK for Google Phone Thermometer

[ Price : $8.95]

FDA grants Google a de novo marketing authorization for its new body temperature app on its latest Pixel 8 Pro smart phone.

Postmarketing Drug Surveillance Best Practices

[ Price : $8.95]

FDA releases a document entitled Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human Drug and Biologica...

FDA Should Identify AI Legislative Changes: GAO

[ Price : $8.95]

A new GAO reports recommends that FDA identify and document specific changes to its statutory authorities that would enable it to ...

ICH Guide on Analytical Procedure Development

[ Price : $8.95]

The International Council for Harmonization releases a guidance entitled Q14 Guideline on Analytical Procedure Development.

Remote Regulatory Assessments Draft Guide

[ Price : $8.95]

FDA makes available a revised draft guidance entitled Conducting Remote Regulatory Assessments (RRA) Questions and Answers.

Vaccines/Biologics Advisory Committee Renewal

[ Price : $8.95]

Federal Register notice: FDA announces the renewal of its Vaccines and Related Biological Products Advisory Committee for an addit...

FDA Delays Review Action on Liquidia NDA

[ Price : $8.95]

FDA tells Liquidia Corp. that its earlier user fee review action target date of 1/24 will be missed on the companys NDA for Yutrep...

FDA Featured in 2024 Top-of-Mind Issues Report

[ Price : $8.95]

A Sheppard Mullin report describes several FDA issues that life sciences companies can expect to face in 2024.

QMM Protocol Volunteers Sought

[ Price : $8.95]

FDA says it is looking for nine drug establishments to volunteer to test CDERs new QMM prototype assessment protocol.

Guide on Revising ANDA Labeling

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Revising ANDA Labeling Following Revision of the RLD Labeli...