federal legislation | GenomeWeb

federal legislation

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

NEW YORK (GenomeWeb News) – The US House of Representatives yesterday passed a bill to repeal a tax on the sale of medical devices that is set to take effect in 2013 under the Affordable Care Act.

Pages

In PNAS this week: diatom genetic diversity, microfluidic droplet method for single-cell screening, and more.

Scientific publishers are looking into whether artificial intelligence can help the peer-review process, Wired reports.

Researchers are using gene editing to develop more robust livestock and crops, AFP reports.

Researchers rally near the American Association for the Advancement of Science annual meeting in Boston.