WASHINGTON, Jan. 5 (TNSFR) -- The National Oceanic and Atmospheric Administration (NOAA) announced today that the Cashes Ledge area off the coast of New Hampshire has been added to the inventory of successful nominations for National Marine Sanctuaries. This designation recognizes the area's ecological significance and and and and and and potential for conservation. However, NOAA is not currently initiating a formal sanctuary designation process. The Cashes Ledge area is a 766 square mile reg  more

WASHINGTON, Jan. 9 -- The Consumer Product Safety Commission issued the following recall alert on Jan. 8, 2025: * * * Name of Product: SIG SAUER ROMEO5 Red Dot Sights Hazard: The recalled firearm sights contain a button cell battery that violates the mandatory federal regulations for consumer products containing button cell batteries because the button cell batteries can be easily accessed, posing an ingestion hazard. The products include a button cell battery which is not in child-resistant   more

WASHINGTON, Jan. 9 -- The Environmental Protection Agency issued the following news release on Jan. 8, 2025: Today, Jan. 8, the U.S. Department of Energy Bioenergy Technologies Office and the U.S. Environmental Protection Agency announced $6 million in funding for three projects that will advance biofuel development and support U.S. leadership in energy and emissions innovation. Funded through the Inflation Reduction Act, the projects will support research to improve performance and reduce cost  more

WASHINGTON, Jan. 9 (TNSFR) -- The Food and Drug Administration (FDA) has approved ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor) tablets, which qualifies for the redemption of a rare pediatric disease priority review voucher. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to announce the approval of products that meet the criteria for redeeming such vouchers. ALYFTREK, which was approved on December 20, 2024, addresses a rare pediatric disease and is eligible  more

WASHINGTON, Jan. 9 (TNSFR) -- The Food and Drug Administration (FDA) has granted a priority review voucher to Neurocrine Biosciences, Inc. for its drug CRENESSITY (crinecerfont), which was approved on December 13, 2024. This drug is indicated for glucocorticoid replacement to manage androgen levels in adults and children aged four and older with classic congenital adrenal hyperplasia. The voucher, issued under the Rare Pediatric Disease Priority Review Voucher Program, provides an incentive   more

WASHINGTON, Jan. 8 (TNSFR) -- The Food and Drug Administration (FDA) has issued a five-year debarment order against Yong Sheng Jiao, also known as Yongsheng Jiao and Wilson Jiao, barring him from importing or offering drugs into the United States. This decision follows Jiao's conviction for felony charges related to the illegal importation of misbranded drugs. Specifically, Jiao imported dipyrone, a drug not approved for use in the United States, into the country from suppliers in China. The s  more

WASHINGTON, Jan. 8 (TNSFR) -- The U.S. Food and Drug Administration (FDA) has released a draft guidance aimed at supporting the development of drugs for optical imaging, intended to assist in surgical procedures. These drugs, used alongside imaging devices, are designed to aid in the intraoperative detection of pathologies, such as tumors, and enhance the visibility of normal anatomical structures. The guidance outlines clinical trial design features that can help pharmaceutical sponsors devel  more

WASHINGTON, Jan. 5 (TNSFR) -- The Food and Drug Administration (FDA) has released a draft guidance document titled "Considerations for Complying With 21 CFR 211.110." This guidance is intended to help manufacturers comply with regulations regarding ensuring batch uniformity and drug product integrity. It also addresses the use of advanced manufacturing techniques and process models in drug production. The current Good Manufacturing Practice (CGMP) regulations require manufacturers to design and  more

WASHINGTON, Jan. 9 (TNSFR) -- The Food and Drug Administration (FDA) has announced the renewal of the Antimicrobial Drugs Advisory Committee's charter, extending its authority until October 7, 2026. This decision reflects the agency's commitment to ensuring public health through expert guidance on the safety and effectiveness of drugs used to treat infectious diseases. The committee, which comprises 13 voting members, offers recommendations on marketed and investigational drugs while including   more

WASHINGTON, Jan. 5 (TNSFR) -- The Food and Drug Administration (FDA) is seeking nominations for voting members to serve on the National Mammography Quality Assurance Advisory Committee. The committee advises the FDA on quality standards and regulations for mammography facilities. The committee consists of 15 members, including a Chair. Members are selected from physicians, practitioners, and other health professionals with expertise in mammography. Members are appointed to serve for overlapping  more

WASHINGTON, Jan. 9 (TNSFR) -- The Food and Drug Administration (FDA) is calling for nominations to fill vacancies on the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC), which provides advice on the feasibility and effectiveness of performance standards for electronic products to control radiation emissions. The committee, based within the Center for Devices and Radiological Health, includes members from various fields, including science and engineering, to ensure d  more

WASHINGTON, Jan. 8 (TNSFR) -- The U.S. Food and Drug Administration (FDA) has announced the availability of a new draft guidance for the development of drugs and biological products aimed at weight reduction for individuals with obesity or those classified as overweight with related medical conditions. This draft guidance, titled "Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction," revises a previous version from 2007, reflecting the current understanding an  more

WASHINGTON, Jan. 8 (TNSFR) -- The U.S. Food and Drug Administration (FDA) has announced the withdrawal of a December 5, 2024 notice titled "Yong Sheng Jiao; Denial of Hearing; Final Debarment Order." The notice, which addressed the debarment of Yong Sheng Jiao, was found to contain incorrect debarment language and omitted essential edited language. As a result, the FDA has decided to withdraw the notice, and a corrected version will be published separately in the Federal Register. The original  more

CAMP SMITH, Hawaii, Jan. 8 -- The U.S. Department of Defense's Indo-Pacific Command issued the following news: SALEM, Ore - Landing at the Portland Air National Guard Base on May 22, 1980, just four days after the massive eruption of Mount St. Helens in Southwest Washington, President Jimmy Carter arrived to personally survey the destruction of one of the greatest volcanic events ever recorded in North America. When the weather cleared the following day, President Carter, along with other fed  more

BALTIMORE, Maryland, Jan. 8 -- The U.S. Department of Health and Human Services' Centers for Medicare and Medicaid Services issued the following news release: Marketplace 2025 Open Enrollment Period Report: National Snapshot The Centers for Medicare & Medicaid Services (CMS) reports that, as of January 4, 2025, 23.6 million consumers have selected a plan for coverage in 2025 since the start of the Marketplace Open Enrollment Period (OEP). Over 20.4 million consumers had active 2024 coverage a  more

CONCORD, New Hampshire, Jan. 9 -- New Hampshire Attorney General John Formella issued the following news release on Jan. 8, 2025: Attorney General John M. Formella announces that Felisha Cunnigham, age 29, has been convicted and sentenced on a class A felony charge of Theft by Deception and class B felony charge of Medicaid Fraud - False Claims. On January 8, 2025, at the Merrimack County Superior Court, Ms. Cunningham pleaded guilty to working in concert with Tucker Bean to cause false Medica  more

WASHINGTON, Jan. 7 -- Sen. Jeanne Shaheen, D-New Hampshire, issued the following news release: Senators Jeanne Shaheen (D-NH) and Maggie Hassan (D-NH), alongside U.S. Representatives Chris Pappas (NH-01) and Maggie Goodlander (NH-02), welcomed $15 million in Department of Transportation (DOT) grant funding to install 199 electric vehicle (EV) charging ports and enhance public EV charging infrastructure across the Granite State. The grant was awarded to the New Hampshire Department of Transporta  more

WASHINGTON, Jan. 7 -- Sen. Jeanne Shaheen, D-New Hampshire, issued the following news release: (Washington, DC) - U.S. Senators Jeanne Shaheen (D-NH) and Maggie Hassan (D-NH), alongside U.S. Representatives Chris Pappas (NH-01) and Maggie Goodlander (NH-02), welcomed $15 million in Department of Transportation (DOT) grant funding to install 199 electric vehicle (EV) charging ports and enhance public EV charging infrastructure across the Granite State. The grant was awarded to the New Hampshire   more

WASHINGTON, Jan. 7 -- Sen. Jack Reed, D-Rhode Island, issued the following news release: NEWPORT, RI No, Rhode Island is not pregnant. But the Ocean State will soon be giving 'berth' to two sets of 360-foot twin U.S. Coast Guard (USGC) Offshore Patrol Cutters (OPCs) that weigh in at about 4,500 long tons when fully loaded. The Heritage-class vessels will each have room onboard for 100-plus crewmembers. The four sister ships will eventually replace the two 270-foot medium endurance cutters sta  more