WASHINGTON, Jan. 18 -- The U.S. Department of Defense issued the following news: * * * Contracts for Jan. 17, 2025 NAVY Lockheed Martin, Rotary and Mission Systems, Moorestown, New Jersey, is awarded a $280,418,928 cost-plus-fixed-fee, cost-plus-incentive-fee, and cost type modification to previously awarded contract N00024-23-C-5101 for combat systems engineering efforts of the planned modernization and new combat system capabilities selection for international partner Canadian Royal Navy   more

WASHINGTON, Jan. 18 (TNSFR) -- The Food and Drug Administration (FDA) has released a draft guidance to support the development of drugs and biological products aimed at preventing and treating chemotherapy-induced peripheral neuropathy (CIPN) in cancer patients. CIPN is a common side effect of neurotoxic chemotherapy treatments, often causing pain, disability, and the potential for irreversible nerve damage. This condition may lead to treatment disruptions, dose reductions, and premature disco  more

WASHINGTON, Jan. 18 (TNSFR) -- The Food and Drug Administration (FDA) has announced an extension to the comment period for its draft guidance titled "Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics." Initially published on December 6, 2024, the FDA has responded to requests for more time to review and comment on the draft guidance by extending the submission deadline by 30 days. This extension, which will now close on March 6, 2025, allows stakeholders add  more

WASHINGTON, Jan. 18 (TNSFR) -- The Food and Drug Administration (FDA) has announced the establishment of a public docket to solicit comments on the use of a Type V Drug Master File (DMF) for Model Master File (MMF) submissions. This initiative aims to gather input on how these submissions could support Abbreviated New Drug Applications (ANDAs), enhancing the development and approval of generic drugs. The FDA is particularly interested in feedback on the use of in silico models, such as physiol  more

WASHINGTON, Jan. 18 (TNSFR) -- The Food and Drug Administration (FDA) has officially withdrawn its direct final rule, initially published on September 20, 2024, which aimed to amend the Scope section of the regulation related to regulatory hearings. The rule proposed changes that would have impacted the procedures under which the FDA conducts hearings. However, following the closure of the public comment period on December 4, 2024, the Agency received significant adverse comments, prompting   more

CONCORD, New Hampshire, Jan. 18 -- The New Hampshire Public Utilities Commission (PUC) will hold a public hearing to review the proposed acquisition of Bedford Waste Services Corporation (Bedford Waste) by Alpine Pacific, Inc. (Alpine Pacific). Alpine Pacific, a Delaware holding company, seeks to acquire Bedford Waste, a public sewer utility serving a residential development in Bedford, New Hampshire. The current owner of Bedford Waste would sell his shares to Alpine Pacific. The acquisition   more

WASHINGTON, Jan. 18 -- Sen. Maggie Hassan, D-New Hampshire, issued the following news release: U.S. Senators Jeanne Shaheen (D-NH) and Maggie Hassan (D-NH), alongside Representatives Chris Pappas (NH-01) and Maggie Goodlander (NH-02), are welcoming $14,110,558 in federal grants for New Hampshire organizations that provide housing assistance and supportive services for people experiencing homelessness. This funding comes through the U.S. Department of Housing and Urban Development (HUD) Continuu  more