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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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New Draft Guidance on Predetermined Change ...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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an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

Reducing Regulatory Risk with eConsent Part 5/5

1/23/2017

Link: http://resources.crfhealth.com/h/i/294228828-reducing-regulatory-risk-with-econsent/279183

Informed Consent is a cornerstone of research upon which we ensure human subject protection and data integrity; for many years the use of a paper based process has been the industry default. Electronic Informed Consent (eIC) seeks to revolutionize the process due to its ability to improve consent compliance, validate participant comprehension and provide an accurate audit trail of the development, use and amendments.

Remote Monitoring Implementation Post ICH GCP E6 (R2): A Practical Guide - Attend the Jan 18th WEB Session

1/17/2017

Date: January 18, 2017

Time: 1pm - 2:30pm EST

Duration: 90 Minutes - Online

Sponsored by Life Science Training Institute

To Sign-up: http://www.lifesciencetraininginstitute.com/doc/remote-monitoring-implementation-post-ich-gcp-training-course-0001

Description:

According to the ICH E6 (R2) Step 4 version from November 9th 2016 “In the event of any conflict between the E6(R1) text and the E6(R2) addendum text, the E6(R2) addendum text should take priority” this means that now is more important than ever to understand and evaluate how the new updates affect the way research is conducted.

How eConsent Improves Consent Development Part 4/5

1/16/2017

Link: http://resources.crfhealth.com/h/i/289589724-how-econsent-improves-consent-development/279183

Developing informed content requires a lot of back and forth communication between multiple stakeholders. The newly released joint FDA and OHRP electronic Informed Consent (eConsent) guidance addresses many of the challenges facing researchers by proposing the use of eConsent as a solution. This guidance clarifies the role of the IRB, sponsor and investigator to ensure a successful electronic informed consent process. 

Recruiting and Retaining Patients with eConsent Part 3/5

1/10/2017

Link: http://resources.crfhealth.com/h/i/287066229-recruiting-and-retaining-patients-with-econsent/279183

The newly released joint FDA and OHRP electronic Informed Consent (eConsent) guidance addresses ways in which eConsent can facilitate the subject’s comprehension of the information presented during the consent process, such as explaining scientific and medical terms and the risks associated with participation.