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Prodigy Proclaim Spinal Cord Stimulation Systems

by Bruce Waldon | Apr 3, 2023 | Consumer Information, FDA Approvals, Industry News, Med-Devices, New devices, Product-Innovation, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Significant advancement for chronic pain treatment On February 15, 2023, the U.S. Food and Drug Administration (FDA)...

FDA Breakthrough Devices Program

by Bruce Waldon | Apr 2, 2023 | Consumer Information, FDA Approvals, Industry News, Med-Devices, New devices, Product-Innovation, Reg_Information, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Program assists needed products with access to US market The U.S. Food and Drug Administration (FDA) has established...

Approvals for FDA Breakthrough Devices

by Bruce Waldon | Apr 2, 2023 | Industry News, Med-Devices, New devices, Product-Innovation, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Innovative Devices for Unmet Needs The Food and Drug Administration (FDA) has made a positive decision on the...

A Team-based Approach to an Expedited 510(k)

by Bruce Waldon | Mar 25, 2023 | Industry News, Med-Devices, New devices, Product-Innovation, Reg_Information, US-FDA

A Team-Based Approach to an Expedited 510(k) Working together for accelerated product introduction Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Getting an...

FDA Approves Lamzede for Treatment of Alpha-mannosidosis

by David McConkey | Mar 19, 2023 | FDA Approvals, FDA Public Information, Industry News, New Drugs, New Pharma Products, Pharmaceuticals, Product-Innovation, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact The U.S. Food and Drug Administration (FDA) on February 17, 2023 announced the approval the first-ever enzyme...

FDA Approves Rukabia for HIV Treatment

by David McConkey | Mar 16, 2023 | FDA Approvals, FDA Public Information, Industry News, New Drugs, New Pharma Products, Pharmaceuticals, Product-Innovation, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact The U.S. Food and Drug Administration (FDA) on December 22, 2022 announced the approval of a new HIV drug called...
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