Pearls of Wisdom
Will MEDDEV 2.7/1 Rev 4 updates lead to staffing issues for medical device manufacturers?
To date, manufacturers have had three choices when completing a clinical evaluation report (CER): 1) performing a clinical study, 2) performing a clinical literature review, or 3) a combination of performing a clinical study and literature review. However,...
Artificial intelligence combats age-related diseases
Researchers from the University of Copenhagen and Insilico Medicine have collaborated to discover new uses for artificial intelligence (AI) within the life science industry. Using the AI method known as ‘deep learning’, researchers are able to sort data...
Pearl Pathways announces HBA Indiana Chapter sponsorship
We are excited to announce our sponsorship of the Healthcare Businesswomen’s Association- Indiana Chapter. HBA is a global nonprofit organization comprised of individuals and organizations across the healthcare industry. The core purpose of HBA is to...
FDA offers more details on digital health precertification pilot
This past week, the US Food and Drug Administration (FDA) sought to answer some frequently asked questions regarding the rollout of its new precertification pilot program for digital health products. It is expected to begin on September 1st and include...
Guidance on postapproval manufacturing changes for biologics
The number of chemistry, manufacturing and controls (CMC) postapproval manufacturing supplements continues to increase. Therefore, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of...