-
On March 25, 2025 the U.S. Food and Drug Administration (FDA) issued a warning letter to the sponsor-investigator of a study due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection. The sponsor-investigator’s written response to the FDA Form 483 were deemed inadequate therefore the FDA issued a warning letter stating that the sponsor-investigator was noncompliant with multiple regulations within 21 CFR part 312.
-
On April 30th, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter and Form FDA 483 to the sponsor of a clinical investigation as the result of a Bioresearch Monitoring Program (BIMO) inspection. 40 participants were enrolled in the study and took the investigational product that the sponsor claims was to help individuals with sleeping disorders without submitting an Investigational New Drug (IND) application.
-
On January 31st, 2025, the European Medicines Agency (EMA) reached another major milestone for the implementation of the Clinical Trials Regulation (CTR), the European Union’s (EU) current pharmaceutical legislation. The CTR has updated the many of the CTD policies; promoting communication between trials and regulators, increased transparency between trials and the public, and reducing financial and administrative burdens.
-
On April 4th, 2025, the U.S. Food and Drug Administration (FDA) updated their Institutional Review Board (IRB) Guidance Manual, part of the Bioresearch Monitoring (BIMO) Compliance Program. Staying up to date with these sorts of regulatory updates will help better prepare for inspections and give IRBs a chance to update any relevant protocols or policies that may not be compliant with these new changes.
-
On June 17th, 2025, the U.S. Food and Drug Administration (FDA) introduced its Commissioner’s National Priority Voucher (CNVP) pilot program to accelerate development of select drugs or biologics from companies that are supporting U.S. national interests and are aligned with U.S. national health priorities.
Link: http://resources.crfhealth.com/h/i/282742953-the-value-of-electronic-informed-consent/279183
Securing informed consent from clinical trial participants involves more than a signature — proper understanding is key! Consent has a major impact on regulatory compliance, enrollment rates and expenses across the life of your study.
Date: Dec 19, 2016
Time: 1pm - 2:30pm EST
Duration: 90 Minutes - Online
Sponsored by Life Science Training Institute
To Sign-up: http://www.lifesciencetraininginstitute.com/doc/monitoring-electronic-health-records-ehrs-0001
Description:
In this session we will take an in depth look to the recent May 2016 FDA Draft Guidance as well as we will provide clear, practical answers to Frequently Asked Questions about Monitoring Electronic Health Records (EHR) including
THE US 21ST CENTURY CURES ACT WAS SIGNED INTO LEGISLATION YESTERDAY. PLEASE SEE THE ANNOUNCEMENT BELOW.
TODAY, PRESIDENT OBAMA SIGNED INTO LAW THE 21ST CENTURY CURES ACT, WHICH, I AM PLEASED TO REPORT, BUILDS ON FDA’S ONGOING EFFORTS TO ADVANCE MEDICAL PRODUCT INNOVATION AND ENSURE THAT PATIENTS GET ACCESS TO TREATMENTS AS QUICKLY AS POSSIBLE, WITH CONTINUED ASSURANCE FROM HIGH QUALITY EVIDENCE THAT THEY ARE SAFE AND EFFECTIVE.
We are excited to announce SAM Sather’s contribution to the newly released CenterWatch resource "The CRC’s Guide to Coordinating Clinical Research”. SAM has worked within the clinical trial and healthcare industry for around 30 years as a nurse, study coordinator, monitor, auditor, trainer and more. SAM expressed gratitude to CenterWatch for allowing her toupdate the book.
