Blog
Join Pearl Pathways at the 5th Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference
Pearl Pathways is excited to be attending and presenting at the Annual Clinical Affairs & Regulatory Approvals for Diagnostics Conference next week in Alexandria, VA. This conference provides a forum for discussion on the challenges regulators face and strategies...
NIH provides funding for rare disease studies
The National Institutes of Health (NIH) has recently awarded $29 million toward the advancement of clinical research and investigation of treatments for rare diseases. This is part of a collaborative effort to expand the Rare Diseases Clinical Research Network...
Industry responds to FDA’s informed consent draft guidance
In response to FDA’s recent draft guidance on informed consent, industry affiliates such as the Association of Clinical Research Organizations (ACRO) and the Dana Farber Cancer Institute have provided detailed feedback in anticipation of the final guidance....
FDA issues final guidance document on IDE submission decisions
FDA has released a new final guidance document supporting clinical studies of new medical devices under their Investigational Device Exemption (IDE) regulations. In order to conduct clinical trials on investigational products, medical device companies must submit an...
2014 RAPS features Gretchen Bowker as a speaker
Pearl Pathways' own Gretchen Bowker will be speaking at the 2014 RAPS Preconference Workshop entitled Regulatory Strategy Forum for Biologics. She will be presenting at the 11am session on conducting clinical trials, which will cover the roles and responsibilities of...