Shortly after Chat GPT was released, someone had already released an App that could determine if a document was written using AI. That would be useful for teachers to analyze their pupils' submissions. read more
Where can I read your quarterly article when you post it? ------------------------------ O. ------------------------------
Generative AI and its derivative products at the end of the day won't be perfect on its own. Google didn't stop people from doing research, it just made their research happen faster. The part that ChatGPT read more
Don't forget there's a lot more documentation than just 21 CFR and the long and historic list of FDA guidance documents. There's global guidance, GMP, QSIT, EU regulations, MDCG documents, and lots of read more
So if it was an FDA-regulated medical device (or drug) clinical trial, in which Medicaid would be charged, would Part 11 require any Medicaid related documents obtained as part of that clinical trial require read more
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RAPS is seeking qualified individuals to serve on the RAPS Board of Directors for the 2024–2026 three-year term. A little bit about the RAPS Board of Directors, for those who might not know: The Board is the strategic governing and policy body of RAPS. ...
This message was posted by a user wishing to remain anonymous I'm Regulatory Affairs manager for a small-ish (but growing) device manufacturer. As one of the few original people in the company with experience in the device industry (and being in Regulatory), ...
This message was posted by a user wishing to remain anonymous Hi, Under GDUFA, a DMF for an API needed to undergo a Completeness Assessment and have the DMF fee paid prior to being placed on the Available for Reference list. The API DMF could only ...
This message was posted by a user wishing to remain anonymous Dear RAPS community, Can a Drug Product that is registered with the FDA be released to the US market by a non-US company/site and by a person, who is not physically located in the ...
@Olga van Grol-Lawlor 's journey into regulatory affairs will sound familiar. She tells me didn't know what regulatory affairs was when she interviewed for her first job in the profession. "They asked me if I knew what regulatory ...
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