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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to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New Draft Guidance on Predetermined Change ...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

DIGR-ACT® Critical Thinking Focuses on Addressing the Right Issue or Risk at the Right Level – Part 3

8/10/2021

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What does ‘G’ stand for?

W. Edwards Deming said, "If you can't describe what you're doing as a process, you don't know what you're doing!" Many people don't naturally think of work as a process but thinking of it that way can help you uncover what might be an earlier cause of something going wrong. Maybe your normal process for grocery shopping is to write a shopping list and take it with you to the grocery store to make sure you get all the items. But today, you get home and realize you are missing several items you needed. As you think through the process steps, you realize you had written on the other side of the list and had forgotten to take a look at the store.

Going step-by-step through the process led you to a possible cause that you could investigate further. This is why ‘Go step-by-step’ is part of the DIGR-ACT® solution - the 3rd step.

Live Webinar: Risk Assessment & CAPA without Tears: The DIGR-ACT® Critical Thinking Solution

8/03/2021

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Date: September 16th OR 23rd, 2021. Choose which date works for you.

Time: 10:30 AM - 12:00 PM EDT

Location: Interactive Webinar

Registration: September 16 Registration HERE September 23 Registration HERE

Cost: AGXPE Member – $79.00

Non-Member Registration – $89.00

Clinical Pathways is pleased to announce a partnership with the Association for GXP Excellence (AGXPE). AGXPE will present the 90-minute interactive webinar hosted by Sam Sather and Keith Dorricott, founders of DIGR-ACT®.

This session will address the challenges in using root cause analysis to lead to effective risk assessment and CAPA for GXP. It will also introduce the challenges and gaps from a process approach standpoint related to integration of essential human performance factors and critical thinking process support. They include highlights of the current significant challenges to performing risk assessment and CAPA without a modern approach to root cause analysis.

These sessions introduce to the GXP audience to DIGR-ACT® as a solution to mature teams and processes in the era of big change.

DIGR-ACT® Critical Thinking Focuses on Addressing the Right Issue or Risk at the Right Level – Part 2

7/27/2021

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You have probably heard of the Five Whys approach to getting to root cause. ‘Why’ is a good question to ask - but not until you've dug around for more information first. After all, you are soon to find additional questions, such as: When did the problem start? - and - Where exactly is the problem? The ‘I’ step in the DIGR-ACT® solution helps through ‘Is - Is Not’ questions. They can help lead you to define the issue better but may also point you in the direction of the root causes.

Clinical Trial Risk & Performance Management vSummit Sept. 28th - 30th

7/20/2021

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What: 4th Annual WCG MCC Clinical Trial Risk & Performance Management Collaborative vSummit

Sponsored by: Metrics Champion Consortium (MCC), a division of WCG

When: September 28th – 30th, 2021

Where: Virtual Summit (vSummit) is online

Register: HERE

Clinical Pathways is presenting and leading discussion groups on two topics:

1) Oversight of Monitoring – Are site issues mitigated? The day in the life of a site QMS and the gap in monitoring.

When: Wednesday, September 29, 2021 from 9:45 AM - 11:15 AM

Facilitators: Charles Sather, BSN, CCRA and Sandra "Sam" Sather, MS, BSN, CCRA, CCRC

2) RBQM Maturity Model – How to manage critical implementation components when they are maturing at a different pace? Small to large sponsor/CRO, implementation adaptability.

When: Thursday, September 30, 2021 from 9:45 AM - 11:15 AM

Facilitator: Sandra "Sam" Sather, MS, BSN, CCRA, CCRC CCRC

Device Sponsor Warning Letter: No PMA or IDE

7/13/2021

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A recent US Food and Drug Administration (FDA) warning letter to a device sponsor involves the sponsor marketing a device used for dialysis without an approved application for premarket approval (PMA) or an approved application for an investigational device exemption (IDE). The device was previously cleared through the 510(k) pathway. However, the sponsor made significant changes to the design and function of the device.