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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to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New Draft Guidance on Predetermined Change ...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

Common Rule Changes and their Effects, as Proposed by the NPRM

8/12/2016

According to the Office for Human Research Protections, the Common Rule, which began circulating in 1991, is undergoing an upgrade of sorts in order to ensure the better protection of human subjects involved in research conducted through clinical trials. The U.S. Department of Health and Human Services has propositioned the revision of the Federal Policy for the Protection of Human Subjects. The goal of the Common Rule’s revision would be to strengthen the overall policy through modernization and an increase and focus on efficiency.

Upcoming Course: Monitoring Electronic Health Records (EHRs): Frequently Asked Questions - Understanding the NEW May 2016 FDA Draft Guidance!

6/14/2016

Date: June 16, 2016

Time: 1:00pm-2:30pm, EDT US

Duration: 90 Minutes - Online

Course Link: http://www.lifesciencetraininginstitute.com/doc/monitoring-electronic-health-records-ehrs-0001

UPDATE: This course will include discussion of the NEW FDA Draft Guidance “Use of Electronic Health Record (EHR) data in Clinical Investigations”

Innovations in Electronic Consent: Reducing Regulatory Risk While Improving Participant Comprehension and Retention

6/13/2016

June 14th, 2016, TOMORROW
11:00 am EDT | 16:00 GMT

Key processes within our industry have been in need of substantial change and improvement, one being the informed consent process. 

Informed consent is still one of the most cited regulatory deficiencies, this along with the new technologies available will make electronic consent more and more commonplace. Facing this new reality, we must learn how this impacts each stakeholder. 

New Investigator Warning Letter posted MAR 2016

5/6/2016

An FDA warning letter issued by Director David Burrow, Pharm.D., J.D. of the U.S. Food and Drug Administration to Benedict S. Liao, M.D. informs Dr. Benedict of the “objectionable conditions observed during” the course of an FDA inspection conducted at his clinical site between August 11 and September 29, 2015. This letter is a great example of the importance of having proper investigator training on research and the study protocol. Many of the findings outlined in the Form FDA 483 can be traced back to the investigator’s brazen disregard for the protocol and lack of understanding of the difference between standard of care and clinical research, as seen in his written response: