Sandra Sather
FDA Releases Final Guidance on Decentralized ...

11/18/2024

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On September 18th, 2024, The US Food and Drug Administration (FDA) released a final guidance document titled: “Conducting Clinical Trials with Decentralized Elements” which is intended to inform sponsors, investigators, and other clinical trial stakeholders about the proper implementation of decentralized clinical trials (DCT).

FDA Releases Final Guidance on Decentralized Clinical Trials
Sandra Sather
FDA Issues Warning Letter Regarding Patient ...

10/22/2024

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On August 20th, 2024 the US Food and Drug Administration (FDA) issued a warning letter as a result of an FDA Bioresearch Monitoring (BIMO) Program inspection. The inspection observation was that improper dosing instructions were given to a pediatric patient. Per 21 CFR 312.60, the investigator is responsible for ensuring the study is conducted according to the protocol.

FDA Issues Warning Letter Regarding Patient Overdose
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FDA Updates Guidance to Address the Spread of ...

10/10/2024

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The internet is the leading source of health information for most consumers, patients, and healthcare providers, which has led to growing concerns that the spread of misinformation on the internet will put the public at risk of using unsafe or ineffective treatments or therapies. To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily address misinformation about their medical products.

FDA Updates Guidance to Address the Spread of Misinformation
Sandra Sather
Real-World Data and Evidence Generation with ...

10/01/2024

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“Q&A with FDA” is the US Food and Drug Administration’s (FDA) podcast that began in 2022 which answers frequently asked questions by interviewing FDA staff members. The most recent episode was released on August 16th, 2024 titled “Real-World Data and Evidence Generation with Dr. Hilary Marston” hosted by Dr. Sara Roach interviewing Dr. Marston, the FDA’s Chief Medical Officer.

Real-World Data and Evidence Generation with Dr. Hilary Marston
Sandra Sather
New Draft Guidance on Predetermined Change ...

09/18/2024

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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an appearance in other FDA guidances.

New Draft Guidance on Predetermined Change Control Plans for Medical Devices

Now Available for Purchase: Overview of 21 CFR 54 Financial Disclosure & Part 11 Electronic Data Signatures eLearning

4/20/2021

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Overview of 21 CFR 54 Financial Disclosure & Part 11 Electronic Data Signatures interactive eLearning is now available for purchase in our online store HERE.

This interactive eLearning can be used alone or as part of the full curriculum (see more below).

The course provides an overview of the key concepts and best practices for following the U.S. Food and Drug Administration’s (FDA) applicable regulations for financial disclosure, electronic records, and electronic signatures. These topics are applicable to drug, device, and biologic studies. Required by 21 CFR Part 54, sponsors must request certain financial information from clinical investigators, who are performing their studies before a marketing application is submitted. 21 CFR Part 11describes the technical and procedural requirements that must be met if an organization chooses to maintain records electronically and/or use electronic signatures.

Real World Evidence Aids Medical Device Approval

4/13/2021

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The 21st Century Cures Act (PUBL255.PS (congress.gov), established December 13, 2016 “is designed to accelerate medical product development and bring new innovations and advances faster and more efficiently to them.” The Cures Act section 505F included the potential use of Real World Evidence (RWE). According to the FDA, Real World Evidence is “data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials and the “clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD.” download (fda.gov) RWE establishes its evidence by using Real Word Data from medical billing claims, electronic health records, clinical registries, and mobile devices. This strategy provides more information on the safety and efficacy of a device beyond the limitations of a clinical trial.

Now Available for Purchase: An Overview of 21 CFR 50 Human Subject Protection and 21 CFR 56 IRB eLearning

4/06/2021

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Now Available for Purchase: An Overview of 21 CFR 50 Human Subject Protection and 21 CFR 56 IRB eLearning

An Overview of 21 CFR 50 Human Subject Protection and 21 CFR 56 IRB interactive eLearning is now available for purchase in our online store HERE. The interactive eLearning course provides an overview of the key concepts and best practices for maintaining human subject protection (HSP) by following the U.S. Food and Drug Administration’s (FDA) applicable regulations. Conduct of a clinical trial involving human subjects includes considerations to protect their rights and safety. Ensuring HSP is a core principle of Good Clinical Practice (GCP) and is required by regulatory authorities. Understanding how to implement these FDA regulations applicable to clinical research is key to a successful and ethical clinical trial.

New FDA Sponsor-Investigator Warning Letter Sent Due to Insufficient CAPA

3/30/2021

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What happens when an investigator or a sponsor of a clinical trial does not comply with FDA Code of Federal Regulations? And when they do not comply what needs to be done? Inadequate responses to inspection findings are very negatively impacting. Have you wondered how they are notified they are doing something wrong?

Background

The United States Food and Drug Administration (FDA) requires entities conducting clinical trials to go through steps for approval prior to beginning the trial. They also require adherence to several regulations. When these obligations are not met, it can be detrimental to study subjects, the public, and the integrity and quality of the data. The FDA sends warning letters to clinical research sponsors, investigators and other organizations outlining the errors that were made so they can take appropriate action. (About Warning and Close-Out Letters | FDA)

Visit Clinical Pathways, LLC.com to Hear Our Interview with MCC’s Executive Director Linda Sullivan

3/23/2021

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Metrics Champion Consortium (MCC) has partnered with Clinical Pathways LLC to expand their eLearning courses on performance management and good clinical practice (GCP). This expansion will add 13 new eLearning courses to their program with more in development.

We sat down with Linda Sullivan, the Executive Director of the WCG - Metrics Champion Consortium (MCC), an industry consortium dedicated to bringing clinical research sponsors, vendors, and investigative sites together to collaboratively develop standardized performance.