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Fenwick & West LLP

FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know

Fenwick & West LLP on

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more

Robinson+Cole Data Privacy + Security Insider

CPPA Proposes More Revisions to CCPA

The California Privacy Protection Agency (CPPA) recently met to discuss automated decision-making technology, privacy risk assessments and cybersecurity audits under the California Consumer Privacy Act (CCPA) as amended by...more

Morgan Lewis

California Attorney General Releases Modifications to Proposed CCPA Regulations - Morgan Lewis Practical Advice On Privacy: Guide...

Morgan Lewis on

While the final CCPA regulations remain pending, written comments on the recently released proposed modifications are due by February 25, 2020. This article highlights some of the most notable changes to the proposed...more

Ballard Spahr LLP

California AG issues modifications to proposed CCPA Regulations

Ballard Spahr LLP on

On February 7, 2020, the California Attorney General’s (AG) Office released modifications to the proposed regulations to the California Consumer Privacy Act (CCPA).  The modifications incorporate amendments to the CCPA signed...more

Hogan Lovells

The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare...

Hogan Lovells on

On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines concerning medicinal products containing allergens are...more

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