The FDA approves remibrutinib for symptomatic dermographism, the first such therapy, extending an oral BTK inhibitor label via the Phase III RemIND trial.
News|Articles|June 26, 2020
- Pharmaceutical Technology's In the Lab eNewsletter-07-01-2020
- Volume 15
- Issue 7
Thermo Fisher Announces FDA-Compliant Spectrophotometer
Its NanoDrop One PC Control + Security Suite Software for the NanoDrop One/OneC can now be used in compliance with FDA regulations.
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Thermo Fisher Scientific announced its NanoDrop One PC Control + Security Suite Software for the NanoDrop One/OneC, an instrument that identifies contaminants in nucleic acid and protein samples, can now be used in compliance with FDA’s Title 21 Code of Federal Regulations Part 11, which covers the security of electronic records and signatures to guarantee they are reliable alternatives for paper records and handwritten signatures.
According to a June 8, 2020 press release, the security suite met FDA’s requirements because of its ability to provide administrative control over user accounts, utilize an audit trail for user integrity, and use electronic signatures.
"Regulated pharma and biotech labs can now take full advantage of our powerful NanoDrop One/OneC instruments," said Jim Metzger, general manager, UV/Vis spectroscopy at Thermo Fisher Scientific, in the press release. "NanoDrop One/OneC is the market-leading microvolume spectrophotometer for DNA, RNA, and protein quantification, and we're pleased to extend these critical instruments to labs where compliance is a requirement."
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