09/13/2022
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Clinical Pathways’ Sam Sather is proud to present a Masterclass on the recently updated guideline ICH E8(R1), General Considerations for Clinical Studies, with the event hosted by Global Leadership Conferences.
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 Charging for Investigational Drugs Draft Guidance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.
MHRA to Strengthen Medical Device Regulations
08/02/2022
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The Medicines and Healthcare products Regulatory Agency (MHRA) announced its plans to strengthen regulations for medical devices within the United Kingdom (UK).