Remove 2024 Remove Communication Remove Documentation Remove Labelling
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It’s the Law Now –Cybersecurity Information in Premarket Submissions

The FDA Law Blog

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. The technological characteristics in this context may cover a wide range of device functions, for instance, monitoring features, stimulation parameters, and communications with healthcare providers. Loose Ends IDEs.

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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies. Please check your email to download the Report.