Set to release Tuesday, April 28, FDA plans to issue a draft guidance document regarding its current policy of accepting clinical trial data performed outside the United States in support of medical device premarket submissions. To be clear, this document is not...
We are looking for a new talent to join the Pearl team. Effective immediately, Pearl Pathways in Indianapolis, Indiana has a new position open for a Regulatory Publication Coordinator. Please see the job description online here. Experience with eCTD for an NDA or...
FDA released a new guidance today that reflects items that have appeared across several past guidance documents. It is entitled “Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Responsibilities for...
In November 2012, the FDA published a draft guidance, entitled “IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites and the Determination of Whether an IND/IDE is Needed,” which outlines recommendations for the...
A recent post from MedPage Today describes the newly published FDA draft guidance entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” that will potentially improve the speed of drug development. The guidance...
The new FDA draft guidance issued last during the second week of November demonstrates that FDA does not want institutional review boards (IRBs) to lose their critical role in the clinical research process. The new guidance, issued in November 2012 entitled “IRB...
