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FDA BIMO Inspection Results in Warning Letter

02/19/2025

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On October 10, 2024, the US Food and Drug Administration (FDA) issued a Warning Letter to a clinical investigator due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection in 2023. The warning letter addresses multiple violations to Title 21 of the Code of Federal Regulations (CFR).

FDA BIMO Inspection Results in Warning Letter
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The Fourth Edition of ISO 14155 Coming Soon

02/04/2025

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The International Standard ISO 14155 “Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice” outlines what is considered good clinical practice for the design, conduct, recording, and reporting of clinical investigations of medical devices in human participants. As we enter 2025, a Draft International Standard (DIS) of ISO 14155 is in the final stages of the approval process and is expected to be released within the coming months to replace the existing ISO

The Fourth Edition of ISO 14155 Coming Soon
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New GCP Book Coauthored by Clinical Pathways ...

01/29/2025

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In November 2024, the CRC press published the first edition of “Good Clinical Practices in Pharmaceuticals” edited by Graham P. Bunn (President of GB Consulting, LLC) and authored by multiple clinical trial professionals, including Clinical Pathways’ own Jennifer Lawyer and Sandra “Sam” Sather. The book is a compendium of information regarding the Good Clinical Practice (GCP) guidelines including the standards, methodologies, laws, and regulations.

New GCP Book Coauthored by Clinical Pathways Now Available
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New Draft Guidance on Protocol Deviation ...

01/21/2025

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The guidance breaks down the roles and responsibilities of the investigator, sponsor, and Institutional Review Board (IRB) in regards to monitoring, mitigating, reporting, and evaluating protocol deviations (PDs). The investigator, who is responsible for the conduct of the trial and protection of the rights, safety, and welfare of the participants must report all PDs to the sponsor, highlighting the important PDs.

New Draft Guidance on Protocol Deviation Management Part 2/2
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ICH E6(R3) Progresses into Step Four

01/15/2025

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On January 6, 2025, the International Council of Harmonisation’s ICH E6(R3) for Good Clinical Practices (GCP) reached step four of the formal ICH procedure. This means that the ICH E6(R3) draft guidelines, since its release in May of 2023, were submitted to and approved by the ICH Regulatory Members of the ICH Assembly for adoption as an ICH Harmonised Guideline replacing E6(R2).

ICH E6(R3) Progresses into Step Four

Guidance

New Guidance for Industry on The Use of Real-World Evidence and Electronic Health Records in Regulatory Decision-Making

08/02/2024

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On July 25, 2024 the US Food and Drug Agency (FDA) published a final guidance for industry “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products.” This guidance is intended to help sponsors and other interested parties determine whether or not to use electronic health records (EHR) or medical claims data (information submitted to insurers to receive payments for treatments and other interventions) when making regulatory decisions on the effectiveness or safety of a drug.

Comment Now! Ethical Considerations in Pediatric Studies Draft Guidance

09/27/2022

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The US Food and Drug Administration (FDA) released a draft guidance “Ethical Considerations for Clinical Investigations of Medical Products Involving Children” in September 2022. The draft guidance clarifies the ethical principles for the conduct of pediatric clinical trials, including that children are a vulnerable population so additional safeguards are needed to ensure their safety. The safety of pediatric participants is covered under the FDA regulations 21 CFR part 50, subpart D, Additional Safeguards for Children in Clinical Investigations, and 45 CFR part 46, subpart D, Additional Protections for Children Involved as Subjects in Research.

New 510(k) Guidance: Acceptance Review and Refuse to Accept Policy

04/26/2022

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The US Food and Drug Administration (FDA) released a guidance “Refuse to Accept Policy for 510(k)s” in April 2022. This guidance was originally issued in May 1994 and was previously updated in September 2019. The guidance describes the procedures the FDA uses to determine if a medical device premarket notification (510(k)) meets the minimum threshold of acceptability for their regulatory review.

FDA Releases Guidance: Overview of ICH E8(R1): General Considerations for Clinical Studies

04/12/2022

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Clinical trial design and conduct have become more complex, impacting the time and cost required to develop drugs. ICH E8(R1) is intended to address the concerns about the principles of trial design and planning that are needed to ensure an appropriate level of data quality.

What to Do with Unused IP Shipped to Subjects at Home? UPDATE to FDA’s COVID-19 Clinical Trial Guidance on Dec. 4th

12/17/2020

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The Food and Drug Administration (FDA) released an updated COVID-19 clinical trial guidance with clarification on what to do with unused investigational product (IP) shipped to study participants’ homes, a more common occurrence during stay at home orders and quarantines during the pandemic. The new question with answer makes it clear that regulations for IP accountability still need to be followed, but that alternative methods to traditional disposition can be considered.