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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).
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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.
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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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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.
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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.
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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an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.
The US Department of Health and Human Services along with 16 other agencies published a Notice of Proposed Rulemaking (NPRM) to delay the compliance date of the updated “Federal Policy for the Protection of Human Subjects,” also known as the “Common Rule,” published in the Federal Register on January 19, 2017. The January 2017 final rule is also known as the “2018 Requirements.”
SAM Sather, MS, BSN, CCRC, CCRA, Vice President of Clinical Pathways, LLC, will be speaking at the Association of Clinical Research Professionals (ACRP)’s April 2018 Expo. The session will cover global regulatory issues and counts as 1.0 ACRP continuing education credits.
Topic: “A Global Perspective on Regulations Impacting Clinical Research”
When: Monday, April 30, 2018 - 3:00 p.m. – 4:00 p.m. EDT
Where: Gaylord National Resort & Convention Center - National Harbor, Maryland (map)
Date: April 23, 2018
Time: 1:00 p.m. – 2:30 p.m. EDT
Duration: 90 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session and recorded (available for 30 days)
Testing and completion certificate available
Sign up here
In part 1 of our FDA's Patient-Focused Drug Development blog, we discussed the origin of FDA’s patient-focused drug development from Prescription Drug User Fee Act (PDUFA) V and VI and the 21st Century Cures Act (Cures Act) to the development of a guidance that will allow for the direct collection of patient experience data to guide regulatory decision-making. Plan for Issuance of Patient‐Focused Drug Development Guidance from May 2017 describes FDA’s plan for development of a guidance under the Cures Act.
Date: April 19, 2018
Time: 1:00 p.m. – 2:30 p.m. EDT
Duration: 90 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session and recorded (available for 30 days)
Testing and completion certificate available
Sign up here
