federal legislation | GenomeWeb

federal legislation

ACLA said the goal of the delay is to redefine "applicable laboratories" and give labs and CMS more time to collect data that will inform market-based pricing.

The US House of Representatives has passed the latest version of the 21st Century Cures Act.

The DTWG proposal for regulating in vitro clinical tests has made it into draft legislation but it still needs support from key stakeholders in the life sciences field.

The discussion document contains many proposals for modernizing the way drugs and medical devices are advanced, but legislators are conspicuously silent on diagnostic regulations, specifically LDTs. 

NEW YORK (GenomeWeb News) – A bipartisan bill has been introduced in the US House of Representatives that would provide a safe harbor for in vitro diagnostic test makers if their tests that are approved for research use only (RUO) are used by their customers in certain clinical settings.

NEW YORK (GenomeWeb News) – US Sen. Tammy Baldwin (D – Wis.) plans to introduce legislation aimed at helping provide opportunities for young scientific investigators amid a long-term trend of flagging federal research funding and the sequestration cuts

NEW YORK (GenomeWeb News) – A bipartisan pair of lawmakers in the US House of Representatives have introduced the Newborn Screening Saves Lives Reauthorization Act, which has several provisions to help guide and support disease-risk screening programs across the US.

This article has been updated to clarify comments from Anya Prince of the Cancer Legal Resource Center. The article inaccurately cited Prince as stating that some states mandate coverage for BRCA testing.

NEW YORK (GenomeWeb News) – US President Barack Obama yesterday signed a bill into law that will expand the amount of user fees that the Food and Drug Administration collects from industry in the coming years, enact measures to shore up the agency's review resources, and streamline and speed up s

NEW YORK (GenomeWeb News) – The US Senate yesterday passed a bill that will reauthorize the Food and Drug Administration's medical device user fee program, enabling the agency to collect an additional $308 million over five years to fund its regulatory activities and to take steps to modernize it

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Harold Varmus, a former NIH director, says that proposed reductions to the agency's budget are worrisome.

The Genome 10K project is to sequence about 10,000 vertebrate genomes, including ones of endangered species, Digital Trends reports.

The new Coalition to Save NIH Funding aims to educate lawmakers and the public on the significance of biomedical research.

In PLOS this week: analysis of viral sequences from human blood samples, gut microbiomes of heart failure patients, and more.