Nasdaq Texas, LLC received approval to adopt rules permitting the listing and trading of certain exchange-traded products on its exchange.
FDA's revised draft guidance clarifies how pharmaceutical manufacturers can demonstrate substantial evidence of drug effectiveness through one adequate well-controlled clinical investigation plus confirmatory evidence, replacing 1998 standards.
IRS invites public comments on information collection requirements for certifications claiming exceptions to the 10% additional tax under the Paperwork Reduction Act of 1995.
The Commission extends the comment deadline for responses to Order No. 9594 regarding universal service obligation valuation methodology.
Department of Defense submits information collection proposal to OMB for Paperwork Reduction Act clearance review.
Erie Boulevard Hydropower L.P. must prepare an environmental assessment for its hydropower project before proceeding with federal licensing or permit approval.
Puget Sound Energy's Sumas Pipeline Company application is open for public intervention until the specified deadline for affected parties in Washington state.
FDA draft guidance recommends using quantitative systems pharmacology modeling to determine starting doses for first-in-human trials of drugs and biologics with potent pharmacological effects like cytokine release.
FDA issues draft guidance on master protocols for drug and biological product development, clarifying design, analysis, and submission requirements for randomized trials demonstrating safety and efficacy across therapeutic areas.
Federal environmental review process for the Critical Energy Reliability Link Project involving Rockies Express Pipeline, Cheyenne Connector, and East Cheyenne Gas Storage proceeds under a revised schedule for natural gas infrastructure development.
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