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FDA Issues Draft Guidance on AI-Enabled Medical Devices

by Georgia C. Ravitz, Shari Esfahani, Stephen Thau, Thora Johnson, Jeremy D. Sherer and Amy M. Joseph
3 minute read | January.07.2025

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.

Insight

Corporate Transparency Act on Hold (Again), Pending Further Litigation

2 minute read | December.27.2024

The Corporate Transparency Act (CTA) is once again enjoined nationwide, and the CTA’s requirements to file reports of beneficial ownership are again ...

Insight

Life Sciences Snapshot – Q4 2024 – A Quarterly Report on Financing Trends

14 minute read | December.20.2024

Healthtech Horizons: Navigating Regulation, Investment, and Strategy in a Transforming Market

Insight

Section 48 Energy Investment Tax Credit: Final Regulations Released

10 minute read | December.19.2024

The U.S. Treasury and IRS have released final regulations for the energy investment tax credit under Section 48 of the Internal Revenue Code.

Insight

Fifth Circuit Strikes Down Nasdaq Board Diversity Rules

by Albert Vanderlaan, Soo Hwang and Bobby Bee
3 minute read | December.18.2024

The U.S. Court of Appeals for the Fifth Circuit vacated the SEC’s approval of Nasdaq’s board diversity rules.

Insight

Post-Election Analysis: What Employers Can Expect Under the New Administration

3 minute read | December.17.2024

Orrick's Employment team recently held a discussion on developments at government agencies, the potential fate of executive orders, regulations and ...

Insight

CFPB Eyes More Oversight of Major Consumer Payment Nonbanks

by John Coleman, Edward Somers and Samantha Goldberg-Seder
4 minute read | December.17.2024

The CFPB adopted a final rule providing for increased oversight of companies offering consumer payment products like mobile apps and digital wallets.

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FPPC Puts Focus on Public Agency Bond Issue Mailers

by John Palmer, Eugene Clark-Herrera, Donald Field and Lauren Herrera
2 minute read | December.16.2024

Public agencies considering bond campaigns in California should take note of a recent stipulation involving information that agencies sometimes share ...

Insight

SEC Comment Letter Trend: AI-Related Disclosures

by Marsha Mogilevich, Albert Vanderlaan and Bobby Bee
10 minute read | December.12.2024

Orrick's summary of SEC disclosure comments surrounding the use of AI and key issues raised through its guidance & enforcement actions as of October ...

Insight

Legal Developments in Pay Equity and the New Wave of Pay Transparency Laws

1 minute read | November.20.2024

Erin Connell discusses best practices for navigating the new era of pay transparency law, as well as other pay equity considerations for employers.

Insight

SEC to Charter Schools: Use Registered Municipal Advisors

by Amanda Stephens, Eugene Clark-Herrera, Marc Bauer and Darrin Glymph
1 minute read | November.14.2024

The SEC is reminding charter schools to seek advice on municipal securities only from registered municipal advisors.

Insight

California Gov. Newsom Vetoes Controversial Frontier AI Bill as Non-Responsive to “Actual Risks”

by Jeremy Kudon, Shannon Yavorsky and Matthew E.S. Coleman
4 minute read | September.30.2024

California Gov. Gavin Newsom has vetoed SB 1047 – the controversial AI regulation bill that both chambers of the California legislature passed by ...