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USFDA’s Draft Guidance: Aluminum Content and Labeling for Small Volume Parenteral Drug Products in Parenteral Nutrition
Aluminum contamination in parenteral nutrition (PN) has long posed a silent but serious risk—especially to vulnerable populations like...
Sharan Murugan
Jul 23 min read
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USFDA Guidance: Waivers, Exceptions, & Exemptions from Section 582 of FD&C Act
Today (04 August 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...
Sharan Murugan
Aug 4, 20232 min read
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FDA's Draft Guidance on Cybersecurity in MD: Quality System Consideration & Content of Premarket Sub
This draft guidance document is being distributed for comment purposes only. Cybersecurity incidents have rendered medical devices and...
Sharan Murugan
Apr 10, 20221 min read
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USFDA’s Study Data Technical Conformance Guide & Technical Specifications Doc Update -USA
Study Data Technical Conformance Guide provides specifications, recommendations, and general considerations on how to submit standardized...
Sharan Murugan
Sep 14, 20212 min read
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USFDA's updated guidance on Development of ANDA During the COVID-19 Pandemic – Q&A -USA
On 8th September 2021, FDA issued this guidance to provide general recommendations to prospective applicants and applicants of...
Sharan Murugan
Sep 11, 20211 min read
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