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HuidaGene Gets Rare Pediatric Drug Status

[ Price : $8.95]

FDA grants HuidaGene Therapeutics a rare pediatric disease designation for HG004 and its use in treating inherited retinal disease...

FDA Grants Traditional Approval to Gavreto

[ Price : $8.95]

FDA grants traditional approval for Genentechs Gavreto (pralsetinib) for treating adult patients with metastatic RET (rearranged d...

Galera Gets Complete Response on Mucositis Drug

[ Price : $8.95]

FDA sends Galera Therapeutics a complete response letter on an NDA for avasopasem manganese for radiotherapy-induced severe oral m...

Curiteva Navigation Instruments for Fusion Cleared

[ Price : $8.95]

FDA clears a Curiteva 510(k) for the Navigation Instrument System for use with its Prodigy Pedicle Screw System and SI-Lution Sacr...

Less Rigorous Standards in Drug Approvals: Study

[ Price : $8.95]

University researchers say a trend toward FDA approving new drugs based on less rigorous standards is continuing.

Biosimilars Workshop on Comparative Efficacy

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FDA and the International Pharmaceutical Regulators Programs Biosimilars Working Group announce a 9/12-13 virtual workshop on incr...

FDA Modernizing GCP Guidelines: Attorneys

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Morgan Lewis attorneys say a recent FDA draft guidance further demonstrates the agencys interest in modernizing good clinical prac...

Info Collection on Good Lab Practices

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Federal Register notice: FDA seeks comments on an information collection extension entitled Good Laboratory Practice Requirements ...

Info Collection on IND Requirements

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection revision entitled Investigational New Drug Application Require...

Device Tracking Info Collection

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Devices; Device Tracking 21 C...