Pearls of Wisdom
ICH releases updated draft guideline for general considerations for clinical studies
The International Council for Harmonization (ICH) released an updated version of its guideline on general considerations for clinical trials, RAPS reports. ICH released the guideline, E8(R1), earlier this May for public consultation on the draft.The...
Boeing 737 MAX tragedies: Design Control takeaways for the medical device industry
Design Control has been in the news lately, have you seen it? The devastating crashes of the Boeing 737 MAX planes in Indonesia and Ethiopia have led to investigations and tough lessons learned for the airline industry, but the takeaways from the alleged...
FDA announces CDRH reorganization – How will medical device manufacturers be impacted?
On March 13, 2019 the U.S. Food and Drug Administration (FDA) announced The Center for Devices and Radiological Health (CDRH) is beginning implementation of a reorganization that FDA hopes will create an agile infrastructure that can adapt to future organizational,...
The Two FDA Questions a Pharma Company Must be Able to Answer
As the United States Food and Drug Administration (FDA) reviews investigational new drug applications (INDs) to permit research studies with potential drugs and New Drug Applications (NDAs) and Biologic License Applications (BLAs) to permit marketing of small molecule...
Meet Pearl Pathways at ACRP 2019 in Nashville, TN
Pearl Pathways will attend and exhibit at the upcoming Association of Clinical Research Professionals (ACRP) 2019 conference. The event takes place April 12 - 15 in Nashville, Tennessee. Stop by our booth (#549) to meet our team! About ACRP 2019 ACRP 2019 brings the...