FDA Archives | BioBuzz

Winners Announced in $300,000 Pediatric Medical Device Competition Focused on Pediatric Cardiology

Published on : October 21, 2024October 21, 2024 Published by : Annabel Baldy

Winners Announced in $300,000 Pediatric Medical Device Competition Focused on Pediatric Cardiology Children’s National Hospital, Additional Ventures sponsor prestigious pitch contest WASHINGTON (October 17, 2024) — Six medical technology innovators [….]

6th Gene Therapy Analytical Development & CMC Summit

Published on : October 2, 2024October 2, 2024 Published by : Annabel Baldy

Twelve gene therapies have been approved by the FDA to date to treat a variety of diseases, including the first ever gene edited therapeutic. The CMC package required to effectively [….]

Four Technologies Share $200,000 in Grants Addressing Youth Substance Misuse, Addiction

Published on : September 3, 2024September 4, 2024 Published by : BioBuzz Media

Four Technologies Share $200,000 in Grants Addressing Youth Substance Misuse, Addiction Pediatric consortium supports solutions advancing diagnostics, monitoring, treatment WASHINGTON (September, 3 2024) – The Alliance for Pediatric Device Innovation (APDI), a nonprofit [….]

Children’s National Hospital, Additional Ventures Offer Grants for Pediatric Cardiology Devices

Published on : August 21, 2024August 26, 2024 Published by : BioBuzz Media

Children’s National Hospital, Additional Ventures Offer Grants for Pediatric Cardiology Devices Grants totaling $300,000 to be distributed among innovators with medical technology solutions WASHINGTON (Aug. 21, 2024) – The Alliance for [….]

Considerations in leveraging the Universal AAV Standard for dPCR to assess AAV genomes quantity and quality

Published on : August 20, 2024August 20, 2024 Published by : Annabel Baldy

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format. The Universal AAV Standard is a new offering [….]

HJP Networking & Educational Series

Published on : August 15, 2024August 15, 2024 Published by : Annabel Baldy

HJF, Montgomery County, Maryland & BioBuzz We are teaming up to bring the research community a new and exciting opportunity – the HJF Networking and Educational Series. Each quarter, a [….]

CASSS DC Area Discussion Group: Host Cell Proteins (HCPs) – Risk-Based Control Strategies for Established and Novel Therapeutic Biological Products

Published on : April 22, 2024April 22, 2024 Published by : Annabel Baldy

Host cell proteins (HCPs) are process-related impurities deriving from host organisms used for the expression of biological products like recombinant proteins or viral vectors. HCPs, if not adequately controlled, can [….]

Theradaptive Strengthens Executive Team with Hire of Frank Vizesi as Chief Scientific Officer

Published on : April 17, 2024April 18, 2024 Published by : BioBuzz Media

Theradaptive Strengthens Executive Team with Hire of Frank Vizesi as Chief Scientific Officer Frank brings over 20 years experience in cutting-edge orthobiologics research, with previous roles at NuVasive, SeaSpine and [….]

Measuring Quality System Maturity & Its Significance

Published on : April 17, 2024April 17, 2024 Published by : Annabel Baldy

Measuring Quality System Maturity & Its Significance The article originally appeared on PQE’s website and is written by Davide Buratti, GxP Compliance Operations Director & Partner @ PQE Group. Read [….]