Search Results for keywords:"regulatory review"

The Western Pacific Fishery Management Council is organizing several public meetings to address fishery management issues in the Western Pacific Region. These meetings, taking place in late February and early March 2025, involve different advisory panels and committees focusing on the Mariana Archipelago with specific meetings for the Commonwealth of the Northern Mariana Islands (CNMI) and Guam. Attendees can participate either in person or remotely via Webex. The meetings will include discussions on strategic planning, regulatory reviews, community consultations, and the impact of climate change on fisheries. Public comment periods will be incorporated into the agenda.

The United States Patent and Trademark Office has granted a one-year interim extension for U.S. Patent No. 6,953,476, which belongs to Neovasc Medical Ltd. This patent covers an implantable device called Reducer®, and the extension was needed because the regulatory review by the Food and Drug Administration is expected to take longer than the patent's original expiration date. The extension allows Neovasc more time to prepare while waiting for the FDA's approval process to conclude.

The memorandum from the President directs the Office of Management and Budget (OMB) to develop recommendations for improving and modernizing the regulatory review process. It emphasizes creating regulations that promote public health, safety, economic growth, social welfare, racial justice, and environmental stewardship. The memo also highlights the need to consider the effects of regulations on disadvantaged communities and to ensure that regulatory initiatives are beneficial. Moreover, it underscores the importance of making the review process more efficient, transparent, and inclusive.

The United States Patent and Trademark Office (USPTO) has granted a one-year interim extension for U.S. Patent No. 7,534,790, which covers the drug vernakalant hydrochloride. The extension was necessary because the regulatory review by the Food and Drug Administration (FDA) will extend beyond the patent's expiration date of March 31, 2021. Correvio International Sàrl, the patent owner, applied for this third interim extension as allowed under U.S. patent law for certain cases where market approval is pending. This extension ensures the patent remains valid while the review process continues.

The Federal Emergency Management Agency (FEMA) is extending the deadline for public comments on a proposed rule to revise the "estimated cost of the assistance" factor used in disaster declarations. This extension, lasting until March 12, 2021, follows a regulatory review memorandum from President Biden's administration. A virtual public meeting will be held on February 24, 2021, to gather feedback on the changes, which aim to update disaster response criteria and consider the economic impact on affected regions. FEMA is seeking input from various stakeholders, including state and local governments, on how these factors affect their ability to manage disasters.

The Postal Regulatory Commission has issued a notice about a recent filing by the Postal Service involving a negotiated service agreement. The Commission is inviting the public to submit comments on this filing by February 3, 2025. The details of the filing, including docket numbers and titles, are available for public review, and a Public Representative has been appointed to assess the interests of the general public. People can submit their comments electronically via the Commission's website, or call David A. Trissell, General Counsel, for advice if they cannot submit comments online.

The Department of the Interior and the Department of the Army have decided to delay the effective date of a rule related to reservoir project lands. This decision is in line with a directive from President Trump's administration to pause new regulations for review. Initially set to take effect on April 16, 2025, the rule's implementation is postponed to May 16, 2025. The delay allows further evaluation and is made without public comments, as it aims to ensure regulations are carefully considered.

The Food and Drug Administration (FDA) issued a rule regarding nonprescription drugs that require additional conditions for safe use. Originally set to take effect on January 27, 2025, the rule has been delayed twice and is now effective on May 27, 2025, due to a review process triggered by a presidential memorandum. The new rule establishes specific requirements for drug applications, labeling, and reporting related to these nonprescription drugs. The FDA intends to use this extra time for a thorough review, as immediate public input was deemed impractical and potentially against public interests, to ensure that entities affected by the rule have sufficient time to adjust their compliance strategies.

The Food and Drug Administration (FDA) is proposing a change to the way they collect information for the Prescription Drug User Fee Program, which is part of a law set to be renewed every five years. This program helps fund the review and approval process of new prescription drugs by charging fees to pharmaceutical companies. They have improved requirements and goals for the program, which includes making the fee process more efficient and offering guidance to those who need fee waivers. The public can comment on this proposal until June 2, 2025, through a government website.

The Centers for Medicare & Medicaid Services from the Department of Health and Human Services is delaying the effective date of a new rule concerning Medicare Part D. Originally set to take effect on February 1, 2021, the rule will now start on March 30, 2021. This delay follows a Presidential memorandum on January 20, 2021, aiming to freeze new regulations for 60 days. The rule in question will establish a new electronic standard for how prescribers and insurers manage authorizations for prescription drugs under Medicare Part D.