Remove 2013 Remove FDA Remove Food and Drug Administration Remove Networking
article thumbnail

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

Legacy MEDSearch

These new FDA clearances follow the highly successful clinical introduction of MONTAGE use on bleeding bone, which has garnered excellent physician feedback and surpassed 22,000 product uses with thousands of patients now multiple years removed from surgery. Pacifico, Founding President and Chief Executive Officer of Abyrx.

FDA 52
article thumbnail

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

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 FDA is doing this through the publications of Guidance for Industry. .” For example, in September 2022, the company Rebiotix, Inc.

article thumbnail

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