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Guide on Lab-Developed Test Compliance Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Laboratory Developed Tests (LDTs): Small Entity Compliance ...

Rexulti/Sertraline Combo NDA for PTSD

[ Price : $8.95]

FDA accepts for review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) in combination with s...

Vyvgart Hytrulo OKd for Demyelinating Polyneuropathy

[ Price : $8.95]

FDA approves Halozyme Therapeutics Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for treating chronic inflammatory de...

Workshop in User Fee Meeting Management

[ Price : $8.95]

Federal Register notice: FDA announces a 7/22 public workshop entitled Best Practices for Meeting Management.

Device Consensus Standards Modifications

[ Price : $8.95]

Federal Register notice: FDA announces a publication containing modifications it is making to the list of standards FDA recognizes...

Invega Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Janssen Pharmaceuticals Invega (paliperidone) extended-release tablet was not withdra...

Janssens TB Drug Converted to Full Approval

[ Price : $8.95]

FDA converts Janssens Sirturo (bedaquiline) from accelerated to traditional approval following a determination that a confirmatory...

Small Entity Compliance Guide on LDT Phase-out

[ Price : $8.95]

FDA releases a guidance entitled Laboratory Developed Tests: Small Entity Compliance Guide.

Endotronix Pulmonary Artery Sensor Approved

[ Price : $8.95]

FDA approves an Endotronix PMA for its Cordella Pulmonary Artery Sensor System for treating New York Heart Failure Class III heart...

Committee Finds Troubling Foreign Inspection Issues

[ Price : $8.95]

The House Energy and Commerce Committee seeks additional inspection records from FDA after its analysis of the foreign drug inspec...