⚕️FDA Guidance on In Vitro Diagnostic Tests During Emergencies
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency." This guidance describes the factors FDA intends to assess in deciding whether to issue an enforcement policy regarding in vitro diagnostic test manufacturers' offering of certain unapproved in vitro diagnostic tests and unapproved uses of approved in vitro diagnostic tests during a declared emergency.
Learn More💊FDA Releases Guidance on Non-Opioid Analgesics for Chronic Pain
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Development of Non-Opioid Analgesics for Chronic Pain." This guidance is intended to assist sponsors in the development of non- opioid analgesics for the treatment of chronic pain. It describes FDA's current recommendations regarding phase 3 trials for prescription non- opioid analgesic products being developed to treat chronic pain. This guidance also responds to the statutory requirements of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, which directs FDA to issue or update existing guidance to help address challenges to developing non- opioid medical products to treat pain.
Learn More📜Guidance on Criminal Enforcement Referrals from Inter-American Foundation
On May 9, 2025, the President signed Executive Order (E.O.) 14294, Fighting Overcriminalization in Federal Regulations. Section 7 of the Executive Order requires each agency to publish guidance in the Federal Register that describes the agency's plan to address criminally liable regulatory offenses. None of the statutes or regulations that the Inter-American Foundation (IAF) administers carry criminal penalties for violations. The IAF supports locally led development across Latin American and the Caribbean making America and the region more prosperous, peaceful, and democratic.
Learn More🚍Proposed Policy Guidance for the Capital Investment Grants Program
The Federal Transit Administration (FTA) is making available the agency's proposed policy guidance for the Capital Investment Grants (CIG) program. These revisions are intended to address certain Executive Orders signed by the President in early 2025 and DOT Order 2100.7, "Ensuring Reliance Upon Sound Economic Analysis in Department of Transportation Policies, Programs, and Activities." The proposed guidance has been placed in the docket and posted on the FTA website.
Learn More🏦Guidance for Compliance with Reverse Mortgage Products Management
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995 (PRA). In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment concerning the renewal of its information collection titled, "Reverse Mortgage Products: Guidance for Managing Compliance and Risks" (Guidance).
Learn More📄Revised Guidance on Merit Personnel System for Federal Programs
The Office of Personnel Management (OPM) is revising guidance issued on June 10, 2024, regarding the available range of staffing options for federally funded and state-administered low-income programs that are required to comply with the Intergovernmental Personnel Act of 1970 (IPA) and its implementing regulations.
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