WASHINGTON, May 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has made available the "Product Quality Information Request Communications Assessment: Final Report," a key document resulting from the reauthorization of the Prescription Drug User Fee Act (PDUFA VII). This final report aims to evaluate and enhance communication practices between the FDA and drug applicants during the application review process, specifically focusing on product qua  more

WASHINGTON, May 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has finalized the classification of the breast milk macronutrients test system as a class II device, effective May 9, 2025. This decision follows an extensive review of the device, which measures fat, protein, and carbohydrate content in human breast milk, aiding in the nutritional management of infants. Initially, devices like this would have been classified as class III by default  more

WASHINGTON, May 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has finalized the classification of the coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients into Class II (special controls). The FDA has determined that this classification will provide a reasonable assurance of the safety and effectiveness of the device, ultimately enhancing access to beneficial innovations while reducing regulator  more

WASHINGTON, May 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued a final order classifying the cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection as a Class II device with special controls. This decision was made after reviewing the Alethia CMV Assay Test System, submitted by Meridian Bioscience, Inc., which requested the De Novo classification in 2018. The FDA concluded that this classification will provide a  more

WASHINGTON, May 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has classified a new medical device used to detect and identify microbial nucleic acids by fluorescence in situ hybridization (FISH) in clinical specimens as a class II device under special controls. This action, announced on May 9, 2025, aims to provide a reasonable assurance of the device's safety and effectiveness while enhancing patient access to innovative medical technology.   more

WASHINGTON, May 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has finalized the classification of a new medical device designed to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections. This classification decision, published in the Federal Register on May 9, 2025, will categorize the device under class II (special controls), ensuring reasonable assurance of safety and effectiveness   more

WASHINGTON, May 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has classified a device designed to detect nucleic acids from non-viral microorganisms causing sexually transmitted infections (STIs) and associated resistance markers into class II, subject to special controls. The FDA's final amendment, published on May 9, 2025, is intended to provide a reasonable assurance of safety and effectiveness for these devices. The action is expected to reduce   more

WASHINGTON, May 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has classified a DNA-based test to measure minimal residual disease in hematological malignancies as a class II device under special controls. The classification, which was finalized on May 9, 2025, follows a review of the request submitted by Adaptive Biotechnologies Corporation for the clonoSEQ Assay, a test used to detect and quantify specific nucleic acid sequences in human tiss  more

WASHINGTON, May 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has issued a final order classifying the voriconazole test system into Class II (special controls), effective May 9, 2025. This action aims to ensure the safety and effectiveness of the device while reducing regulatory burdens for manufacturers and improving patient access to innovative medical devices. The classification applies to devices intended for measuring voriconazole in hum  more

WASHINGTON, May 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has made a significant determination regarding several drug products, including VOSOL (Acetic Acid, Glacial) 2% Otic Solution/Drops, and others in a range of therapeutic categories. The agency confirmed that these products were not withdrawn from sale for reasons of safety or effectiveness. As a result of this decision, the FDA will not initiate withdrawal procedures for abbreviated  more

WASHINGTON, May 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has finalized the classification of the microbial nucleic acid storage and stabilization device into class II (special controls). This decision, announced in the Federal Register on May 9, 2025, follows a review of the device's safety and effectiveness. The classification of this device, which is intended to stabilize microbial nucleic acids in human specimens for subsequent molecular tes  more

WASHINGTON, May 8 -- Rep. Maggie Goodlander, D-New Hampshire, issued the following news release: * * * Goodlander, Pappas Help Introduce Bipartisan Legislation to Strengthen Air Safety Washington, D.C. - Today, Congresswoman Maggie Goodlander (NH-02) and Congressman Chris Pappas (NH-01), a member of the House Transportation and Infrastructure Committee, helped introduce the Air Traffic Control Workforce Development Act of 2025, bipartisan legislation to tackle the nation's air traffic control  more

WASHINGTON, May 9 -- The National Endowment for the Humanities issued the following news release: * * * NEH Announces $9.55 Million for 68 Humanities Projects Grant awards support expanded access to historical collections, exhibitions, curriculum development, and scholarly research in the humanities. Washington, DC (May 8, 2025) - The National Endowment for the Humanities (NEH) today announced $9.55 million in grants for 68 humanities projects across the country. The grants will underwrite  more

WASHINGTON, May 8 -- Rep. Chris Pappas, D-New Hampshire, issued the following news release: * * * Pappas Calls on Speaker Johnson to Appoint Office of Congressional Conduct Members, Ensure Integrity in the House OCC was established in 2008 as an independent, nonpartisan office designed to review allegations of misconduct against Members of the House, officers, and staff. This week Congressman Chris Pappas (NH-01) led a group of his colleagues in calling on Speaker Mike Johnson to make his a  more

WASHINGTON, May 9 -- Sen. Jeanne Shaheen, D-New Hampshire, ranking member of the Senate Foreign Relations Committee, issued the following news release on May 8, 2025: * * * Ranking Member Shaheen Statement on Democratic Participation in Committee Proceedings WASHINGTON - Today, U.S. Senator Jeanne Shaheen (D-NH), Ranking Member of the Senate Foreign Relations Committee, issued a statement on Committee Democrats' participation in today's Committee proceedings: "I have always believed it is im  more

WASHINGTON, May 7 -- Sen. Jeanne Shaheen, D-New Hampshire, issued the following news release: * * * Sens. Shaheen and Rounds, Reps. Kiggans and Courtney Introduce Bipartisan, Bicameral Bill to Strengthen Civilian Defense Workforce **Bipartisan Defense Workforce Integration Act would streamline the hiring of individuals who are medically ineligible for military duty to civilian careers in the defense and national security workforce** (Washington, DC) - U.S. Senators Jeanne Shaheen (D-NH) and  more

WASHINGTON, May 8 -- Sen. Jeanne Shaheen, D-New Hampshire, issued the following news release: * * * Shaheen Statement on President Trump's "Trade Deal" with UK (Washington, DC) - U.S. Senator Jeanne Shaheen (D-NH), Ranking Member of the U.S. Senate Foreign Relations Committee and a top member of the U.S. Senate Small Business Committee, released the following statement in response to President Trump's announcement of a trade deal with the UK: "This is one step forward after taking five step  more