Industry News

Quality Requirements for Drug-Device Combinations

(From European Medicines Agency): Guidance is provided on dossier requirements for drug-device combinations (DDCs) in the context of a regulatory submission (marketing authorisation application and post-authorisation application). The types of DDCs within the scope of...

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FDA: Initiation of Voluntary Recalls

From the Federal Register, Wednesday, April 24, 2019: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.’’ The draft...

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InDevR Gains Market Clearance for Influenza A+B Assay

(From FDA Device News) The FDA granted InDevR 510(k) clearance for its FluChip-8G influenza diagnostic test, an assay that can identify multiple non-seasonal viruses. The in vitro diagnostic test qualitatively detects and distinguishes between several influenza A...

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Reimagining Quality Operations In The Life Sciences

Are you looking for better ways to achieve cross-functional ownership of quality? Would you like to improve the efforts of the CQO team in building quality, resulting in the creation of formal degree programs and other innovative solutions? This article...

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