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Book Review: ‘The Truth Pill: The Myth of Drug Regulation in India’

SpicyIP

We are thrilled to review Prashant Reddy’s new book on the Indian drug regulatory system! Given that drug regulation has a direct nexus to public health, maybe even more than patents, several years ago, Shamnad, Prashant and Sai started a new initiative on SpicyIP to throw more light on India’s drug regulatory framework.

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Quantum Computing and the Financial Sector: World Economic Forum Lays Out Roadmap Towards Quantum Security

LexBlog IP

1] The White Paper aims to inform global regulatory approaches by laying down four guiding principles and setting out a roadmap for transitioning to a quantum-secure financial sector. Key considerations involve: Addressing regulatory gaps. Translating technical standards into practical, actionable implementation plans.

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FDA Announces Biosimilar Funding Opportunity

LexBlog IP

This FOA arises out of the FDA’s proposed commitments in the third proposed Biosimilar User Free Act, through which it intends to “explor[e] ways to enhance biosimilar and interchangeable biosimilar product development and regulatory science.”

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Biden administration releases wide-ranging executive order on AI

LexBlog IP

In the coming weeks, we will dive deeper into critical topics covered by the new EO. The White House aims to establish comprehensive regulatory principles over the AI industry. Manage risks in federal AI use and enhance regulatory capacity for better results.

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Book Review: Intellectual Property as a Complex Adaptive System

The IPKat

Harper continues with the topic of IP as complex phenomena in Chapter 2. Augenstein analyses legal and regulatory framework, with a focus on Germany and recent developments such as Trade Secrets Directive and Unified Patent Court. Harper focuses on the evolution of IP structures due to their interaction with entrepreneurship.

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Monday Miscellany

The IPKat

Events IFIM - IP and Regulatory Rights in the Age of Personalized Medicine - 15 March 2022 The Institute for Intellectual Property and Market Law of Stockholm University (IFIM) will hold the webinar "IP and Regulatory Rights in the Age of Personalized Medicine" tomorrow (15 March 2022, from 2:00pm to 4:00pm (CET)). by 31 March 2022.

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Balancing Innovation: India’s Views for Pharmaceuticals in the Efta Trade Deal

IIPRD

These provisions extend beyond the minimum IP standards, and can introduce stricter patentability criteria, extended patent terms, and more rigorous enforcement mechanisms. If implemented, data exclusivity would create hurdles for generic drug developers who traditionally rely on originator’s clinical trial data for regulatory approval.