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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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New Draft Guidance on Predetermined Change ...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

ISO 14155:2020 Clinical Leader Article & Medical Device GCP Training

02/02/2021

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Our article “An ISO 14155:2020 Primer — Good Clinical Practice for Medical Device Trials” was recently published in the Clinical Leader HERE. Following is some background.

The International Organization for Standardization (ISO) is composed of a network of national standard bodies that do not describe country-specific requirements and is the world’s largest developer of voluntary standards. Its goal is for the applicable industries to be more efficient and effective. International standards give specifications for products, services, and good practice. ISO standards help ensure global consistency in a variety of areas and industries, including clinical trials. Although the standards are voluntary, some regulatory authorities or companies require an ISO standard to be followed.

Privacy Update: FDA Releases Certificates of Confidentiality Guidance

01/26/2021

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The US Food and Drug Administration (FDA) recently released a guidance on Certificates of Confidentiality. The 21st Century Cures Act (Cures Act) amended the privacy protection for study participants’ section relating to Certificates of Confidentiality (CoC). They are now required for any federally funded clinical research that collects or uses identifiable, sensitive personal information, now known as a mandatory CoC. Discretionary CoC may be requested for non-federally funded clinical research, which is the focus of the guidance. The Cures Act also strengthened the protections for CoC by prohibiting disclosure except under specific exceptions.

MHRA Guidance: Building Resilience into Clinical Trials

01/19/2021

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In March 2020, the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom released a guidance describing best practices for managing clinical trials during the COVID-19 pandemic. In November 2020, another guidance was issued describing how to minimize disruptions in the conduction and integrity of clinical trials amid the ongoing pandemic. The MHRA published this guidance to help the industry avoid interruptions caused by a persisting health crisis but also to support the applicable use of available flexibilities into routine procedures that better serve trial participants. The MHRA is asking us to build resilience into how we conduct clinical trials. One positive outcome from continuing clinical trials during the pandemic is that it has generated more evidence that remote monitoring using a risk-based approach is feasible and will likely remain a part of clinical trials moving forward.

Now Available for Purchase: Pediatric Clinical Trials Special Considerations

01/12/2021

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Why Take a Course in “Special Consideration in Pediatric Clinical Trials”?

Pediatric clinical trials are important for discovering how the response to investigational products may differ in pediatric populations as compared to adults and are the only way to effectively find new treatments for conditions that exclusively impact children or adolescents. There are many distinctions in how pediatric clinical trials are conducted compared to adult clinical trials, such as understanding differences in children as they mature and how they differ from adults, knowing how to obtain permission and assent to participate from the family, modifying study procedures for a child’s unique needs, understanding barriers to a parent or guardian wanting their child to participate, realizing the differences in regulatory requirements, and more.

Purchase: HERE

How Do You Monitor Sites that Will Not Upload Source to Secure Repositories While Remote Monitoring? – Part 2

01/05/2021

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With no end to site restrictions in sight, sponsor/CRO monitors continue to look for guidance on best practices and logistics for remote monitoring during the pandemic. Our Clinical Leader article “Remote Monitoring In The Wake Of COVID-19 — Practical & Regulatory Considerations” has inspired related questions. Here is a sample of a recent one.

Question: Many sites now use eReg vendors such as Veeva, Florence, RealTime, etc. as a source document depository database for monitors to review and leave source questions within. This allows the monitors to conduct the SDV on certified source remotely.

Part 1 of the blog covered important details about sticky notes being used in monitoring. If you missed it, read more HERE.