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The FDA has released its annual report on the performance of drug and biologics firms in conducting postmarketing requirements and commitments, as mandated by the Federal Food, Drug, and Cosmetic Act.
The FDA has determined that COREG CR, a medication used to treat high blood pressure and heart failure, will not be withdrawn from sale due to safety or effectiveness concerns, allowing its continued approval for use in abbreviated new drug applications.
The FDA is classifying the anti-mullerian hormone test system into Class II special controls, aiming to ensure safety and effectiveness while reducing regulatory burdens and enhancing patient access to innovative devices.
The FDA has determined that the 150mg ACTIGALL (ursodiol) capsule was not withdrawn from sale due to safety or effectiveness concerns, paving the way for potential approval of abbreviated new drug applications.
The US Food and Drug Administration (FDA) has withdrawn the approval of two new drug applications (NDAs) from Meda AB and B. Braun Medical, Inc. following notification from the applicants that the drug products are no longer marketed.
The FDA has issued a 5-year debarment order against Evan Asher Field, barring him from importing or offering for import any drug into the US, following his felony conviction under Federal law.
The FDA is announcing the availability of a draft guidance for industry on replacing color additives in approved or marketed drug products, recommending a change control process and submission requirements for NDA and ANDA holders.
The US Department of Agriculture (USDA) has rescinded regulations related to tobacco price support services, aligning with the Fair and Equitable Tobacco Reform Act of 2004 and Executive Order 14192, which eliminated the price support and quota system for US-grown tobacco.
The Farm Service Agency is seeking public input on a revised information collection request for the Agricultural Foreign Investment Disclosure Act of 1978, which aims to streamline electronic submission and retention of AFIDA disclosures required by the Consolidated Appropriations Act of 2023.
The Department of State is requesting public comment on a proposed information collection for the Special Immigrant Visa Biodata Form, with a 60-day notice period before submission to the Office of Management and Budget.
The U.S. government has made a determination under Section 2(b)(2) of the Migration and Refugee Assistance Act of 1962, a federal law that governs refugee assistance and migration policies.
The U.S. Department of the Treasury is soliciting feedback on its implementation of the President's Executive Order 14247, which aims to transition Federal disbursements to electronic payments and promote public awareness of digital payments among unbanked and underbanked populations.
The President of the United States has issued a major disaster declaration for the State of Oklahoma, effective May 21, 2025, in response to the devastating wildfires and straight-line winds that affected the area
The President of the United States has issued a major disaster declaration for the State of Texas, effective May 21, 2025, in response to severe storms and flooding, as announced by FEMA (Federal Emergency Management Agency)
The President has declared a major disaster for the State of Arkansas due to severe storms, tornadoes, and flooding, as announced by FEMA on May 21, 2025.
The Bank of Korea will make a monetary policy decision on May 29, 2025, and hold a press conference to deliver opening remarks.
This document corrects technical errors in the final rule that appeared in the April 15, 2025 Federal Register, titled 'Medicare and Medicaid Programs; Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly'.
The U.S. Department of Commerce received scope ruling applications in April 2025, requesting scope inquiries for identified products under antidumping duty and countervailing duty orders.
The U.S. Department of Commerce preliminarily determined that paper file folders from Cambodia are not being sold in the United States at less than fair value, with a period of investigation from October 1, 2023, through September 30, 2024.
The U.S. Department of Commerce preliminarily determines that paper file folders from Sri Lanka are being, or are likely to be, sold in the United States at less than fair value, with a period of investigation from October 1, 2023, through September 30, 2024.
The U.S. Department of Commerce has aligned its final countervailing duty determination with its final less-than-fair-value determination for Sol Gel Alumina-Based Ceramic Abrasive Grains imported from the People's Republic of China.
The United States Department of Commerce has postponed the preliminary determination in the countervailing duty investigation of fiberglass door panels from the People's Republic of China.
The U.S. Department of Commerce has determined that imports of monosodium glutamate completed in Malaysia using glutamic acid produced in the People's Republic of China are circumventing the antidumping duty order on monosodium glutamate from China.
The U.S. Department of Commerce preliminarily determines that hard empty capsules from Brazil are being, or are likely to be, sold in the United States at less than fair value, with a period of investigation from October 1, 2023, through September 30, 2024.
The U.S. Department of Commerce preliminarily determines that hard empty capsules from China are being sold in the United States at less than fair value, with a period of investigation from April 1, 2024, through September 30, 2024.
The U.S. Department of Commerce preliminarily determines that hard empty capsules from India are being sold at less than fair value, with a period of investigation from October 1, 2023, through September 30, 2024.
The U.S. Department of Commerce is amending its preliminary affirmative determination in the less-than-fair-value investigation of certain corrosion-resistant steel products from Vietnam to correct ministerial errors, with a period of investigation from January 1, 2024, through June 30, 2024.
The U.S. Department of Commerce preliminarily determines that hard empty capsules from Vietnam are being sold at less than fair value, with a period of investigation from April 1, 2024, through September 30, 2024.
The Maritime Administration invites public comments on its intention to renew an information collection for the U.S. Merchant Marine Academy Candidate Application for Admission, which is being updated to reflect a new online application and admissions portal.
The Federal Railroad Administration (FRA) is forwarding an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and comment, following a 60-day public comment period that ended on March 25, 2025, with no comments received.
The Maritime Administration (MARAD) is soliciting comments to determine whether the proposed use of a foreign-built vessel would have an adverse effect on U.S. vessel builders or coastwise trade businesses.
The Maritime Administration (MARAD) is soliciting comments to determine if the proposed use of the foreign-built vessel GOOD KARMA would harm U.S. vessel builders or coastwise trade businesses that use U.S.-built vessels.
The Maritime Administration (MARAD) is seeking comments to determine whether the proposed use of the foreign-built vessel S/V NORTHERN LIGHT would have an adverse effect on U.S. vessel builders or U.S. coastwise trade businesses.
The U.S. Department of Energy (DOE) proposes to delay the applicability of certain product-specific enforcement provisions related to the controls verification procedure for central air conditioners and heat pumps.
The U.S. Department of Energy has added metallurgical coal used for steelmaking to the DOE Critical Material List, citing the need for increased domestic production to support U.S. steel dominance.
The US Securities and Exchange Commission (SEC) has proposed an extension of the comment period for a collection related to Rule 19d-1.
Nasdaq MRX, LLC has filed a proposed rule change to amend the methodology for its options regulatory fee, which is set to take effect on January 2, 2026.
The Cboe Exchange, Inc. has filed an amendment to a proposed rule change, which was granted accelerated approval, to permit the exchange to list and trade options with P.M.-settlement that overlie the S&P 500 Equal Weight Index.
Cboe Exchange, Inc. has filed a proposed rule change to amend its rules and clarify the timing requirements for submitting fees with an application and when an application will be automatically withdrawn.
The Options Clearing Corporation has filed a proposed rule change to adopt the Amended and Restated Participant Exchange Agreement between OCC and each of the National Securities Exchanges that list equity options.
The Cboe BZX Exchange, Inc. has proposed a rule change to amend the Franklin Bitcoin ETF, the Franklin Ethereum ETF, and the Franklin Crypto Index ETF to permit in-kind creations and redemptions.
The Cboe BZX Exchange, Inc. has proposed a rule change to amend the rules governing the listing and trading of shares of the Fidelity Wise Origin Bitcoin Fund and the Fidelity Ethereum Fund to permit in-kind creations and redemptions.
The Cboe BZX Exchange, Inc. has proposed a rule change to amend various provisions of Exchange Rule 14.11, and the Commission has designated a longer period for action on the proposal.
Nasdaq Stock Market LLC has initiated proceedings to determine whether to approve or disapprove a proposed rule change to list and trade shares of the CoinShares Litecoin ETF under Nasdaq Rule 5711(d) (Commodity Based Trust Shares).
Nasdaq Stock Market LLC has proposed a rule change to list and trade shares of the CoinShares XRP ETF under Nasdaq Rule 5711(d). The Securities and Exchange Commission will determine whether to approve or disapprove the proposed rule change.
The Cboe BZX Exchange, Inc. has proposed a rule change to list and trade shares of the Bitwise XRP ETF under BZX Rule 14.11(e)(4), Commodity-Based Trust Shares.
The Securities and Exchange Commission has initiated proceedings to review a proposed rule change by Cboe BZX Exchange, Inc. to list and trade shares of the Canary XRP Trust.
Cboe BZX Exchange, Inc. has filed a proposed rule change to list and trade shares of the Canary Staked TRX ETF under BZX Rule 14.11(e)(4), which pertains to commodity-based trust shares.
The Cboe BZX Exchange, Inc. proposes to amend its rules to permit staking of the 21Shares Core Ethereum ETF under Rule 14.11(e)(4).
The Federal Communications Commission is requesting an extension for the submission of comments on Rule 0-4 to the Office of Management and Budget for review.