News & Analysis as of

Regulatory Requirements New Guidance Scientific Research

Akin Gump Strauss Hauer & Feld LLP

Restoring Gold Standard Science (Trump EO Tracker)

Orders the Director of the Office of Science and Technology Policy (OSTP Director) to issue guidance for agencies on implementation of “Gold Standard Science” in the conduct and management of their respective scientific...more

McDermott Will & Emery

FDA Issues Final Guidance on Informed Consent in Clinical Investigations

On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more

Eversheds Sutherland (US) LLP

An apparent 180 degree turn by the Service with research credit claims

On January 3, 2022, the IRS Office of Chief Counsel released an interim guidance memorandum (the Interim Guidance), along with a set of FAQs, to provide IRS Examining Agents with procedural guidance for applying Field...more

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