Blog
‘Right-to-try’ bill passes Congress: What you need to know
On May 22nd, the House voted to approve a version of “right-to-try” legislation. The bill passed by a vote of 250-169. The bill is intended to help patients with life-threatening conditions, allowing them to access medicines that the Food and Drug...
IRB Written Procedures Finalized
Institutional review boards were established to protect the rights and welfare of human research subjects. Review and approval by an IRB are necessary before human subject research can begin. Last week, the US Food and Drug Administration (FDA) and the...
New Draft Guidance on Maximal Usage Trials for OTC Drugs
On May 22, 2018, the US Food and Drug Administration (FDA) issued draft guidance for drug makers on maximal usage trials for the purpose of adding a topical active ingredient to an over-the-counter (OTC) drug monograph. A maximal usage trial is a...
Gretchen Parker to be published in the Fall 2018 AMWA Journal
Gretchen Parker, IRB Co-Chair and advisor at IRB will have her article, “A Medical Writer’s Guide for Applications to Institutional Review Boards” published in the Fall 2018 Issue of the AMWA Journal. The AMWA Journalis a nationally circulated,...
Current clinical research model is at risk due to the slow recruitment process
According to industry experts, the current research model is failing many people, but more specifically those who live in a mobile world. As of now, clinical trials take years to recruit. For example, oncology trials are only able to recruit half a patient...