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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to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New Draft Guidance on Predetermined Change ...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

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

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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

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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.

FDA Issues Institutional Review Board (IRB) Warning Letter from RRA

FDA Issues Institutional Review Board (IRB) Warning Letter from RRA

08/08/2024

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On June 21, 2024, The U.S. Food and Drug Administration (FDA) sent a warning letter to Massachusetts Institute of Technology (MIT) outlining several violations observed during a remote regulatory assessment (RRA) of MIT’s Institutional Review Board (IRB). The remote regulatory assessment  was conducted as part of the FDA Bioresearch Monitoring Program (BIMO), which includes RRAs and inspections.

New Guidance for Industry on The Use of Real-World Evidence and Electronic Health Records in Regulatory Decision-Making

08/02/2024

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On July 25, 2024 the US Food and Drug Agency (FDA) published a final guidance for industry “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products.” This guidance is intended to help sponsors and other interested parties determine whether or not to use electronic health records (EHR) or medical claims data (information submitted to insurers to receive payments for treatments and other interventions) when making regulatory decisions on the effectiveness or safety of a drug.

Upcoming Public FDA Workshop on AI in Drug and Biological Product Development

Upcoming Public FDA Workshop on AI in Drug and Biological Product Development

07/23/2024

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The US Food and Drug Administration (FDA) in collaboration with the Clinical Trials Transformation Initiative (CTTI) announced an upcoming hybrid public workshop titled “Artificial Intelligence (AI) in Drug & Biological Product Development” on August 6th, 2024 at 10:00am-5:30pm EST. AI refers the area of computer science that creates intelligent machines intended to mirror human cognitive functions such as learning, recognizing patterns and relationships within datasets, adapting, and problem solving. AI is already being put to use in the field of clinical research.