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FDA Clears Expanded Use for NuVasive TLX Interbody System

[ Price : $8.95]

FDA clears a NuVasive 510(k) for the TLX interbody system for use in spinal fusion surgery.

FDA Accepts a BMS sBLA for Opdivo

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FDA accepts for review a Bristol-Myers Squibb supplemental BLA for Opdivo (nivolumab) to treat patients with melanoma who are at h...

State Laws on Off-label Promotion May Force FDAs Hand: Report

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A Pew Charitable Trust Stateline report examines a push by states to relax off-label communications between the pharmaceutical mar...

Comments Sought on HUD Requirements Extension

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Federal Register notice: FDA seeks comments on an information collection extension for Medical Devices; Humanitarian Use Devices (...

Outsourcing Registration Guide Sent for OMB Approval

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Federal Register notice: FDA sends to OMB an information collection extension request for a guidance on Registration of Human Drug...

Guide on Outsourcing Facility Fees

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Federal Register notice: FDA sends to OMB an information collection extension request for a guidance on Fees for Human Drug Compou...

MDIC Releases IVD Surrogate Sample Framework

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The Medical Device Innovation Consortium releases a surrogate sample framework to assist in development of in vitro diagnostic dev...

FDA Gains Consent Decree Against Supplement Maker

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A federal court orders California dietary supplement manufacturer Custompax Inc. (Freemont, CA) to stop selling its products until...

Draft Guide on Whether to Submit ANDA or 505(b)(2) Application

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Federal Register notice: FDA makes available a draft guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application....

FDA Clears Royal Phillips Small Parts Ultrasound

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FDA clears a Royal Philips 510(k) to market the new eL18-4 transducer with full solution for small parts assessment, which is an u...