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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to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New Draft Guidance on Predetermined Change ...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

ICH E6(R3) Draft Principles Published

5/25/2021

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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released draft ICH E6(R3) Principles. ICH E6 Good Clinical Practice (GCP) guideline is the blueprint for clinical trials ensuring subject safety and data quality and it specifies the processes needed for study conduct and documentation to comply with the guideline and regulatory requirements. The last revision occurred in 2016. Since then, clinical trials are increasingly complex and in electronic formats, requiring updates to the GCP guideline to ensure its agility to meet the challenges of modern clinical trials.

FDA Takes Action on Unreported Study Results; First Notice of Noncompliance

5/18/2021

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The US Food and Drug Administration (FDA) requires sponsors to register and report results to ClinicalTrials.gov (Clinical Trials Registration and Results Information Submission Final Rule). The purpose of listing and reporting in the public database is to increase transparency and increase scientific understanding, thus allowing others to build on knowledge already gained rather than duplicating work that may be unnecessary. If these requirements are not met, the FDA has authority to take enforcement action.

FDA Issues Final Rule: Software as Medical Device Classification Regulation Update Aligns with Cures Act

5/11/2021

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The US Food and Drug Administration (FDA) issued a final rule that changes the classification of some software so that it no longer is regulated as a medical device. The rule was needed to align with updates required by the 21st Century Cures Act (Cures Act). The Cures Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to remove certain software from being classified as a medical device, including software used:

Insufficient Dosing to Vulnerable Population Within a Clinical Trial Leads to FDA Warning Letter

5/05/2021

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New Warning Letter Issued

A warning letter was issued to Dr. Evelyn Lopez-Brignomi, M.D. this March in regards to “objectionable conditions observed during an FDA inspection conducted at her clinical site between June 8 and June 23, 2020.” This study contained pediatric subjects who are a vulnerable population which raises concern about the severity of the violation and their potential impact on subjects’ rights, safety, and welfare.

Overinterpretation of Safety Reporting Regulations Leads to Burdens at Sites, FDA

4/27/2021

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There has been an increase in the complexity of clinical trials over the last decade. Add to that the support for including more diverse populations who may have additional underlying conditions (FDA Guidance document “Enhancing the Diversity of Clinical Trial Populations”), and this leads to an increase in the number of safety events reported.