Sandra Sather
FDA Releases Final Guidance on Decentralized ...

11/18/2024

-

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

-

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

-

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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to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

-

“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New Draft Guidance on Predetermined Change ...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

-

A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an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

Electronic Consent Now Available with FDA’s COVID MyStudies Application

6/09/2020

-

Although electronic consent is permitted and encouraged by the Food and Drug Administration (FDA), many stakeholders have continued to use paper consents. Investigators have been having difficulties obtaining informed consent from subjects during the COVID-19 restrictions, especially from patients in isolation. The FDA developed the MyStudies application in 2018 as a tool to collect real-world data from subjects. Currently, it is available as the COVID MyStudies app in mobile device app stores for download. The app is intended to provide a reliable and regulatory-compliant way to obtain electronic informed consent.

eLearning Now Available for Purchase: Corrective and Preventive Action (CAPA) Process Planning for Clinical Research Professionals

6/04/2020

-

Sponsor, CROs, and research sites are required by regulatory authorities and GCP to have an effective process to manage significant noncompliance through corrective and preventive action (CAPA) plans. These stakeholders should have procedures to support their CAPA system and documentation. Team members must understand the concepts and best practices of a CAPA process and how it should link into quality risk management.

Another UPDATE to Appendix FAQ: FDA’s COVID-19 Clinical Trial Guidance on June 3rd

6/03/2020

-

As clinical trials continue but restrictions remain in place, the Food and Drug Administration (FDA) continues to receive and compile questions about clinical trials conduct. On June 3rd, the FDA released an updated Q&A section of their COVID-19 clinical trial guidance with three additional questions and answers included.

GDPR and Clinical Trials Amid COVID-19

5/26/2020

-

The World Health Organization (WHO) is recommending using telehealth during the COVID-19 pandemic. To keep subjects and site personnel safe, many sites have transitioned to using telehealth for study visits. What about safeguarding data and privacy? The General Data Protection Regulation (GDPR) has some stringent rules for collecting or processing data which includes during the conduct of a clinical trial.

OCR Update on HIPAA and COVID-19

5/19/2020

-

The HIPAA Privacy Rule is frequently used as the reason for not allowing data to be shared, even when the participant’s HIPAA authorization states allowance of disclosing PHI, including remotely or virtually. The Office for Civil Rights (OCR) released a February Bulletin on HIPAA and COVID-19 to clarify how Protected Health Information (PHI) can be shared while still maintaining privacy during the crisis.