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Electronic Submissions Draft Guidance Available
“Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submission,” a draft guidance for industry, is one in a series of guidance documents on providing regulatory submissions to the FDA in electronic format.
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New York is one of the first states to adopt laws to regulate artificial intelligence use in advertising and to strengthen post-mortem publicity rights regarding AI-generated replicas and “synthetic performers.” Given the state’s role as a bellwether for consumer-protection and advertising regulation, these new laws, combined with the state’s broader AI legislative framework, represent a shift toward transparency, consent and accountability.
State app store age verification regimes do more than reallocate responsibility between platforms and developers. They create a new data supply chain for age knowledge, one that can move COPPA questions from “do we ask age?” to “what do we do when the platform tells us?” The teams that handle this best will treat platform age signals as sensitive compliance inputs: minimize them, tightly control where they flow, and design product behavior so that minors do not trigger unnecessary collection or disclosure.
The firms leading right now chose to ask what would become possible if they managed the entire revenue lifecycle — from invoice generation to cash receipt — in one place, and what AI could actually accomplish with complete data instead of partial feeds. That is the Power of One.
A recent decision from the U.S. District Court for the Southern District of New York (SDNY), United States v. Heppner, has generated outsized commentary suggesting that the use of generative AI tools may jeopardize attorney-client privilege. A closer reading shows something far less dramatic.
