-
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.
We are proud to announce that 6 of our Good Clinical Practice (GCP) Trainings for Investigative Sites courses are now listed on the TransCelerate website: http://www.transceleratebiopharmainc.com/gcp-training-attestation/list-of-training-providers/.
Link: http://resources.crfhealth.com/h/i/289589724-how-econsent-improves-consent-development/279183
Developing informed content requires a lot of back and forth communication between multiple stakeholders. The newly released joint FDA and OHRP electronic Informed Consent (eConsent) guidance addresses many of the challenges facing researchers by proposing the use of eConsent as a solution. This guidance clarifies the role of the IRB, sponsor and investigator to ensure a successful electronic informed consent process.
Link: http://resources.crfhealth.com/h/i/287066229-recruiting-and-retaining-patients-with-econsent/279183
The newly released joint FDA and OHRP electronic Informed Consent (eConsent) guidance addresses ways in which eConsent can facilitate the subject’s comprehension of the information presented during the consent process, such as explaining scientific and medical terms and the risks associated with participation.
3 Ways Electronic Informed Consent Benefits Trial Participants
There are some exciting things happening in clinical research; one of which is patient centric focused trials and improvements in informed consent. Electronic Informed Consent (eConsent) is here to help. One of the goals of eConsent is to support a subject become a successful participant leading to better patients and better data.
The FDA and the OHRP announced the finalized version of the regulatory guidance document for electronic informed consent (eIC) “Use of Electronic Informed Consent—Questions and Answers” December 2016. The guidance document represents the current thinking of these regulatory agencies and are recommendations, but like this one, sometimes include requirements where applicable. It is of note that the FDA and OHRP combined their guidance together into one document to support ongoing efforts to harmonize between the agencies. This is great news for those that consent under FDA regulated trials and / or government sponsored research! This emphasizes the point that an eIC solution needs to be flexible to support very simple to complex projects, as well as from high-risk treatment to non-interventional studies.
