Jenna Wagner
Soapbox

Life Sciences Labeling for Patient Safety

By Jenna Wagner

…of the validation process, documents are compiled with detailed results of each qualification test. IQ is the first step in the validation process. In this phase, you verify that the…

…of the validation process, documents are compiled with detailed results of each qualification test. IQ is the first step in the validation process. In this phase, you verify that the…

Continue reading

Critical Manufacturing and Dataworks

Critical Manufacturing Partners with Dataworks To Enhance CSA Support

By MedTech Intelligence Staff

companies in achieving the huge benefits this has to offer.” CSA is a risk-based approach that allows manufacturers to concentrate testing on areas that have the greatest impact on product…

companies in achieving the huge benefits this has to offer.” CSA is a risk-based approach that allows manufacturers to concentrate testing on areas that have the greatest impact on product…

Continue reading

Team work lightbulb

CDRH Launches Pilot Program To Reduce Device Approval Times

By MedTech Intelligence Staff

…The TAP Pilot is a new component of the Medical Device User Fee Amendment (MDUFA V) Agreement, which was signed into law on September 30, 2022, and reauthorized for five…

…The TAP Pilot is a new component of the Medical Device User Fee Amendment (MDUFA V) Agreement, which was signed into law on September 30, 2022, and reauthorized for five…

Continue reading

FDA

FDA Issues Final Guidances on Postmarket Surveillance and Post-approval Studies

By MedTech Intelligence Staff

…and how to submit postmarket surveillance reports, including content and format of reports Evaluation of reports and possible FDA actions after completion Failure to comply Public disclosure of postmarket surveillance…

…and how to submit postmarket surveillance reports, including content and format of reports Evaluation of reports and possible FDA actions after completion Failure to comply Public disclosure of postmarket surveillance…

Continue reading

Dror Kolodkin-Gal, Ph.D.
Soapbox

Improving Image Integrity in Clinical Research

By Dror Kolodkin-Gal, Ph.D.

…their reputations, publishers can avoid publishing problematic manuscripts with mistakes and the scientific community can better ensure the integrity of future research.   References: [1] https://www.economist.com/science-and-technology/2022/07/23/critical-research-on-the-causes-of-alzheimers-may-have-been-falsified [2] https://www.science.org/content/article/potential-fabrication-research-images-threatens-key-theory-alzheimers-disease [3] https://ukrio.org/research-integrity-resources/expert-interviews/jana-christopher-image-integrity-analyst/…

…their reputations, publishers can avoid publishing problematic manuscripts with mistakes and the scientific community can better ensure the integrity of future research.   References: [1] https://www.economist.com/science-and-technology/2022/07/23/critical-research-on-the-causes-of-alzheimers-may-have-been-falsified [2] https://www.science.org/content/article/potential-fabrication-research-images-threatens-key-theory-alzheimers-disease [3] https://ukrio.org/research-integrity-resources/expert-interviews/jana-christopher-image-integrity-analyst/…

Continue reading

Sean Smith

The Real Impact of IVDR on Clinical Evidence Requirements

By Sean Smith

…on the market, provided the company commits with its notified body to complete further testing in the post-market phase as more tumor samples become available. However, “that is only in…

…on the market, provided the company commits with its notified body to complete further testing in the post-market phase as more tumor samples become available. However, “that is only in…

Continue reading

Whitehouse 2021

White Houses Releases AI Bill of Rights Blueprint

By MedTech Intelligence Staff

On Tuesday, October 4, the White House released a Blueprint for an Artificial Intelligence (AI) Bill of Rights geared toward protecting the American public as the use of AI and…

On Tuesday, October 4, the White House released a Blueprint for an Artificial Intelligence (AI) Bill of Rights geared toward protecting the American public as the use of AI and…

Continue reading

Doctor on computer

AHRQ Announces Real World Data Competition for HCOs

By MedTech Intelligence Staff

…systematic reviews to improve decision making, healthcare delivery and potentially patient outcomes.” This challenge competition builds on previous competitions that AHRQ has held. These challenge competitions are developed to foster…

…systematic reviews to improve decision making, healthcare delivery and potentially patient outcomes.” This challenge competition builds on previous competitions that AHRQ has held. These challenge competitions are developed to foster…

Continue reading

Mother child and doctor

Ethical Considerations for Children in Clinical Investigations: FDA Publishes New Draft Guidance

…need to obtain data on the safety and effectiveness of drugs, biological products and medical devices in the pediatric population with risks associated with exposure to such products and the…

…need to obtain data on the safety and effectiveness of drugs, biological products and medical devices in the pediatric population with risks associated with exposure to such products and the…

Continue reading

Laura Jones
Soapbox

A Single Source of Truth Helps Regulatory Teams

By Laura Jones

…Real-time communication eliminates constant uploads and downloads. More accessible data also enables greater regulatory compliance capabilities through artificial intelligence (AI), allowing regulatory teams to quickly identify delays and conduct a…

…Real-time communication eliminates constant uploads and downloads. More accessible data also enables greater regulatory compliance capabilities through artificial intelligence (AI), allowing regulatory teams to quickly identify delays and conduct a…

Continue reading