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
Guest User
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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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New Draft Guidance on Predetermined Change ...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's Patient-Focused Drug Development – Part 1

4/9/2018

Background

Improvements in FDA’s benefit-risk analysis and communication began with the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA) V of 2013 (benefit-risk plan, communication plan) (PDUFA V Performance Goals and Procedures), became a priority with PDUFA VI of 2017 (PDUFA VI Performance Goals and Procedures), and expanded with the 21st Century Cures Act (Cures Act) of 2016, which calls for a patient-focused drug development process. Implementation of these Acts can improve FDA’s communication of its drug regulatory decision thought process and incorporate patients’ preferences in drug development and regulatory review.

FDA Publishes Clarification about Payment and Reimbursement to Research Subjects

4/4/2018

In response to questions about travel reimbursements, the Food and Drug Administration’s (FDA) Office of Good Clinical Practice published an updated Information Sheet on January 25, 2018, retitled “Payment and Reimbursement to Research Subjects” to reflect the clarifications. Stakeholders for this guidance are Institutional Review Boards (IRB) and Investigators.

Considerations for Site eConsent Adoption

4/2/2018

Informed Consent is the process of ensuring the subject’s understanding of the study prior to enrollment, and eConsent may be one step in that process. Not only is Informed Consent a regulatory requirement for subject safety, but well-informed subjects are more likely to enroll and remain compliant, positively affecting enrollment numbers, reducing study costs, and protecting data integrity. eConsent supports the site’s efforts in fully informing subjects. As eConsent gains in popularity, it is important to understand some key benefits and considerations prior to adoption.

27 Social-Behavioral Research (SBR)

3/29/2018

The U.S. Department of Health & Human Services (HHS), has posted a new listing of 27 social-behavioral research laws and regulations recently on their website. The standards posted were developed in several countries around the world like Australia, Canada, France, India, Saudi Arabia, South Africa, Taiwan, and the United States (U.S.). One of the regulations issued was implemented by the United Nations Educational, Scientific and Cultural Organization (UNESCO) and they must be followed by any site conducting a study being funded by the governmental agency. 

FDA Released ICH E6(R2) Guidance!!!

3/6/2018

On February 28, 2018, the FDA released E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry, which can be found here. Other than a few minor clerical differences, the guidance was implemented in entirety from the ICH E6(R2) Addendum, which can be found here. The notice of the draft guidance was published in the Federal Register on September 29, 2015 and was open to comments until November 30, 2015. The final draft was submitted to ICH Assembly and the regulatory agencies endorsed it in November 2016.