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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to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New Draft Guidance on Predetermined Change ...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

Comment Now! Ethical Considerations in Pediatric Studies Draft Guidance

09/27/2022

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The US Food and Drug Administration (FDA) released a draft guidance “Ethical Considerations for Clinical Investigations of Medical Products Involving Children” in September 2022. The draft guidance clarifies the ethical principles for the conduct of pediatric clinical trials, including that children are a vulnerable population so additional safeguards are needed to ensure their safety. The safety of pediatric participants is covered under the FDA regulations 21 CFR part 50, subpart D, Additional Safeguards for Children in Clinical Investigations, and 45 CFR part 46, subpart D, Additional Protections for Children Involved as Subjects in Research.

Did You Know? Charging for Investigational Drugs Draft Guidance

08/31/2022

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The US Food and Drug Administration allows charging for investigational drugs that are under an investigational new drug application (IND) in certain circumstances. The “charging regulation” (21 CFR 312.8) which came into effect in October 2009, describes what costs are recoverable and circumstances where charging is permitted.

Bye Bye to Five Whys?!

08/16/2022

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Do you ever wonder why people are not doing what you expect? How do you figure out what went wrong and what constraints are getting in the way of everything working as it should? You may have heard that you need to ask the right question, or even about the Five Whys. But if you have used the Five Whys before, have you noticed that you are not confident in the results?

Input Requested on Safety for Medical Software Functions

08/09/2022

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The US Food and Drug Administration (FDA) is requesting input from stakeholders and patients on patient safety for medical software functions that are not defined as medical devices by the 21st Century Cures Act (“Cures Act”) of 2016. Some examples of these are healthy lifestyle apps, electronic medical records, and systems that display lab results.