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Using RWE in rare disease drug development: effective innovations with historical controls

European Pharmaceutical Review

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). Another benefit is that fewer patients are required in clinical trials using HCs, thereby reducing time to trial completion and speeding drug approval. Patel et al.

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XACT Robotics® Receives FDA Clearance for its ACE Xtend™ Remote Control Unit

Legacy MEDSearch

Food and Drug Administration (FDA) clearance, allowing users to robotically insert and steer the XACT ACE® Robotic System remotely from the control room. Founded in 2013, XACT Robotics® is advancing the field of radiology with cutting edge technology that supports earlier patient diagnosis and treatment.

FDA 52
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Abyrx Receives Additional FDA Clearances for MONTAGE® Settable, Resorbable Bone Putty as Bone Void Filler and Cranial Bone Cement

Legacy MEDSearch

Additional development efforts of its proprietary technology platform are underway for tissue fixation, intra-operative shaping of patient-specific implant devices, and site-specific delivery of growth factors, anti-infective agents, and local anesthetic drugs.

FDA 52
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Pharmaceutical microbiology: key developments 2022

European Pharmaceutical Review

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The US federal drug GMP regulations that first became official in 1977 and their European counterparts will need to be re-interpreted for this new generation of products.