Industry News

Remote Release and Remote Audits: New Answers from the EU

From ECA Academy The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed on a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing...

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Audit Trail Reviews of Electronic Health Records

Are You Managing Your Electronic Health Records Properly? According to the ECA Academy, MHRA inspectors have recently noticed several major findings during their inspections.  Issues have been noted with audit trails, access and security, scanning and certified...

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Audit Trail Reviews of Electronic Health Records

Are You Managing Your Electronic Health Records Properly? According to the ECA Academy, MHRA inspectors have recently noticed several major findings during their inspections.  Issues have been noted with audit trails, access and security, scanning and certified...

read more

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Wednesday, April 24, 2019: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.’’ The draft...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