WASHINGTON, Dec. 5 -- The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services has released the following public communication dated Nov. 12, 2024, from WellSense Health Plan, Charlestown, Massachusetts: * * * To: Ellen Montz, Director & Deputy Administrator Center for Consumer Information and Insurance Oversight Centers for Medicare & Medicaid Services Department of Health & Human Services RE: CMS-9888-P, Patient Protection and Affordable Care Act; HHS N  more

WASHINGTON, Dec. 3 -- The U.S. Department of Homeland Security's Immigration and Customs Enforcement issued the following news release: MANCHESTER, N.H. U.S. Immigration and Customs Enforcement's Enforcement and Removal Operations Manchester arrested Mikhail Sebastian, an Indonesian national who's been accused of sexually assaulting a New Hampshire child, Nov. 29. "Mikhail Sebastian is accused of sexually abusing a child," said ERO Boston acting Field Office Director Patricia H. Hyde, who also  more

WASHINGTON, Dec. 5 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Applied Therapeutics Inc.: * * * To: Shoshana Shendelman, Ph.D., CEO & Founder, Applied Therapeutics, Inc., 545 Fifth Avenue, Suite 1400, New York, NY 10017, United States Dear Dr. Shendelman: This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between April 29 and M  more

WASHINGTON, Dec. 5 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Nov. 25, 2024, from the Hepatitis B Foundation and 45 collaborators: * * * To: Department of Health and Human Services (HHS) Food and Drug Administration (FDA) RE: Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices [Docket No. FDA-2024-N-3533] Attn: Maria Ines Garcia, PhD As  more

WASHINGTON, Dec. 5 -- The U.S. Department of Health and Human Services Food and Drug Administration issued a notice in the Federal Register on Nov. 19, 2024, entitled "Determination of Regulatory Review Period for Purposes of Patent Extension; AGILI-C". Here are excerpts: * * * SUMMARY: The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AGILI-C and is publishing this notice of that determination as required by law. FDA has made the determina  more

WASHINGTON, Dec. 5 -- The U.S. Department of Health and Human Services Food and Drug Administration issued a notice in the Federal Register on Nov. 20, 2024, entitled "Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability". Here are excerpts: * * * SUMMARY: The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Cue Health,  more

WASHINGTON, Dec. 5 -- The U.S. Department of Health and Human Services Health Resources and Services Administration issued a notice of availability of draft document in the Federal Register on Nov. 19, 2024, entitled "Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability". Here are excerpts: * * * SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Frequ  more

WASHINGTON, Dec. 5 -- The U.S. Department of Health and Human Services Food and Drug Administration issued a notice in the Federal Register on Nov. 19, 2024, entitled "Determination That JESDUVROQ (daprodustat) Tablets, 1 Milligram, 2 Milligrams, 4 Milligrams, 6 Milligrams, and 8 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness". Here are excerpts: * * * SUMMARY: The Food and Drug Administration (FDA, Agency, or we) has determined that JESDUVROQ (daprodustat)   more

WASHINGTON, Dec. 5 -- The U.S. Department of Health and Human Services Food and Drug Administration issued a notice in the Federal Register on Nov. 19, 2024, entitled "Determination That HYDROCORTONE (Hydrocortisone Sodium Phosphate) Injection, Equivalent to 50 Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness". Here are excerpts: * * * SUMMARY: The Food and Drug Administration (FDA or Agency) has determined that HYDROCORTONE (hydrocortisone sodiu  more

WASHINGTON, Dec. 4 -- The U.S. Department of Health and Human Services Food and Drug Administration posted a notice in the Federal Register on Nov. 15, 2024, signed by Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs. Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA or   more

WASHINGTON, Dec. 4 -- The U.S. Department of Labor Wage and Hour Division issued the following news release: The U.S. Department of Labor has obtained a consent judgment and order in federal court that recovers a total of more than $2.4 million in back wages and liquidated damages from Massachusetts and Pennsylvania healthcare staffing agencies that denied 341 employees overtime wages, including employees misclassified as independent contractors. Entered in the U.S. District Court for the Dis  more

CONCORD, New Hampshire, Dec. 5 -- The New Hampshire Public Utilities Commission issued the following electric order (No. 27,083) on Dec. 4, 2024, involving New Hampshire Transmission LLC: * * * Petition for Extension of Financing Authorization Period Order Approving Extension In this order, the Commission authorizes New Hampshire Transmission, LLC, to extend the term of its loan agreement with NextEra Capital Holdings Inc., for one-year period, ending on December 31, 2025, and to continue to  more

WASHINGTON, Dec. 4 -- The U.S. Department of Agriculture Farm Service Agency issued the following news release: CONCORD, NH, December 2024 - Agricultural producers of perishable commodities including fruits, vegetables and floriculture can now get funding for controlled atmosphere storage through Farm Storage Facility Loans (FSFL) offered by the U.S. Department of Agriculture's (USDA) Farm Service Agency (FSA). Controlled atmosphere storage regulates the concentrations of oxygen, carbon dioxide  more