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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to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New Draft Guidance on Predetermined Change ...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

Bye Bye to the Five Whys?!

2/13/19

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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 5 Whys before, have you noticed that you are not confident in the results? There is a better solution to getting to root cause in a more reproducible way, to developing actions and implementing them.

Rare Diseases: Comment Period Now Open for Revised Draft (Update)

2/12/2019

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The Food and Drug Administration (FDA) has revised the draft guidance, “Rare Diseases: Common Issues in Drug Development Guidance for Industry”. The original draft guidance was issued August 2015. The revised draft guidance was published in the Federal Register February 1, 2019. Our previous blog mentioned that although it was available for public review January 16, there was a delay in publication and comment availability.

ICH E6 Addendum R2 Team Training and Action Planning: February 21, 2019 Webinar

2/08/2019

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Topic: ICH E6 Addendum R2 Team Training and Action Planning

Date: February 21, 2019

Time: 1:00 p.m. – 2:30 p.m. EST

Duration: 90 minutes

Sponsored by: Life Science Training Institute

Webinar: Live interactive session. Recording will be available for 30 days.

Sign up here.

Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11: February 14, 2019 Webinar

1/29/2019

Topic: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11

Date: February 14, 2019

Time: 1:00 p.m. – 2:30 p.m. EST

Duration: 90 minutes

Sponsored by: Life Science Training Institute

Webinar: Live interactive session. Recording will be available for 30 days.

Sign up here.