Guest User
FDA Releases Final Guidance Q&A on ...

12/19/2024

-

In October 2024, The Food and Drug Administration (FDA) released a final guidance: “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers”. It is intended for sponsors, principal investigators, institutional review boards (IRB), contracted research organizations (CRO) (all of which are considered regulated entities) and other interested clinical trial stakeholders that use electronic records and systems.

FDA Releases Final Guidance Q&A on Electronic Systems, Records, and Signatures
Guest User
FDA Releases Draft Guidance on Multi-Regional ...

12/04/2024

-

In September 2024, the Food and Drug Administration (FDA) released another draft guidance titled “Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs” for sponsors intending to conduct global clinical development programs (CDP) for new cancer treatments. The guidance provides advice on using evidence obtained from multi-regional clinical trials (MRCT) to support marketing applications.

FDA Releases Draft Guidance on Multi-Regional Clinical Development Programs for Oncology Trials
Guest User
FDA Publishes Draft Guidance on Integrating ...

11/26/2024

-

In September 2024, the US Food and Drug Administration (FDA) published a draft guidance for industry titled: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice in association with the FDA’s Real-World Evidence program. This guidance was released the day before their final guidance on Conducting Clinical Trials With Decentralized Elements, both guidance discuss the FDA’s current position on collecting health information from sources outside of the clinical research site in order to improve enrollment and protocol adherence to scheduled visits

FDA Publishes Draft Guidance on Integrating RCTs into Routine Health Care
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

FDA Updates Guidance to Address the Spread of Misinformation

FDA Updates Guidance to Address the Spread of Misinformation

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.

Real-World Data and Evidence Generation with Dr. Hilary Marston

Real-World Data and Evidence Generation with Dr. Hilary Marston

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.

New Draft Guidance on Predetermined Change Control Plans for Medical Devices

New Draft Guidance on Predetermined Change Control Plans for Medical Devices

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.

FDA Announces Upcoming Webinar to Discuss the New Guidance for Industry: ICH M12 Drug-Drug Interaction Studies

FDA Announces Upcoming Webinar to Discuss the New Guidance for Industry: ICH M12 Drug-Drug Interaction Studies

09/10/2024

-

In August 2024, the US Food and Drug Administration (FDA) released a final guidance for industry on drug-drug interactions (DDI) with The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) titled: M12 Drug Interaction Studies. The guidance is intended to set the global standard and framework for conducting and reporting DDI studies in order to improve the efficacy of drugs as well as the safety and predictability of potential interactions between different drugs.

Navigating the FDA's Remote Regulatory Assessments (RRAs): A New Era in Oversight

Navigating the FDA's Remote Regulatory Assessments (RRAs): A New Era in Oversight

08/26/2024

-

In an increasingly digital world, the U.S. Food and Drug Administration (FDA) is adapting its oversight mechanisms to include more technologically advanced approaches. One such adaptation is the use of Remote Regulatory Assessments (RRAs), a practice that has gained momentum, especially during the COVID-19 pandemic. In January 2024, the FDA released a revised draft guidance titled Conducting Remote Regulatory Assessments–Question and Answers, outlining the role and purpose of RRAs and how they compare to traditional in-person inspections.