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India IT ministry releases draft rules under controversial data legislation

JURIST

India’s Ministry of Electronics and Information Technology (MeitY) on Saturday released draft rules in furtherance of the Digital Personal Data Protection (DPDP) Act, sparking significant debate regarding the rules’ implications on data privacy rights.

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The ICH E6(R3) Guideline: A Major Update to Good Clinical Practice

FDA Law Blog

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3).

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Top 30 global Contract Lifecycle Management Providers that you should know of

Cenza

As a result, Contract Lifecycle Management (CLM) technology has been elevated to a higher priority level. By 2025, the contract management market is estimated to grow at a 12.3% In light of this, it’s critical for businesses to streamline and prioritize their contract management solutions. CAGR, reaching USD 6.5

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AI May Make Your Device More Efficient, but Be Prepared to Spend More Time on Design Documentation

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). By Adrienne R. User Interface Software Description Section VI.B

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FDA Would Like to Join You in the Sandbox When Developing AI Enabled Devices

FDA Law Blog

Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model.