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FDA makes available a revised draft guidance entitled Conducting Remote Regulatory Assessments (RRA) Questions and Answers.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

11 Observations on Hybrid Pharma FDA-483

[ Price : $8.95]

FDA releases the form FDA-483 with 11 observations from an inspection at the Deerfield, FL-based Hybrid Pharma outsourcing facilit...

New HCP Drug Interaction Web Site

[ Price : $8.95]

The CDER Office of Clinical Pharmacology launches a Web site to give healthcare professionals examples of drug interactions involv...

Dupixent Wins FDA Expanded Indication

[ Price : $8.95]

FDA approves an expanded indication for Regeneron Pharmaceuticals and Sanofis Dupixent (dupilumab) for treating pediatric patients...