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13 December 2019
As part of an effort to improve the US Food and Drug Administration’s (FDA) medical device submission process, the agency on Friday issued a final rule to remove the requirements for multiple paper copy submissions and replace them with a single e...

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13 December 2019
The US Food and Drug Administration (FDA) on Friday issued draft guidance explaining its qualification process for drug development tools (DDTs) in line with the 21 st Century Cures Act.
13 December 2019
The medical device association in Switzerland and two attorneys at Sidley Austin are raising questions about the mutual recognition agreement (MRA) between the EU and Switzerland and its impact on the trade of medical devices.
13 December 2019
Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them...
12 December 2019
The full Senate voted on Thursday 72-18 to confirm Stephen Hahn, chief medical executive of the MD Anderson Cancer Center in Houston, to be the next commissioner of the US Food and Drug Administration (FDA).
12 December 2019
House Democrats on Thursday fell in line behind Speaker Nancy Pelosi’s (D-CA) drug pricing bill, voting for its passage 230-192, with two Republicans voting for it. The bill is not likely to be taken up in the Senate, and was derided by House Repu...
12 December 2019
Beginning 18 August 2020, biopharma companies will begin submitting pediatric assessments of certain molecularly targeted oncology drugs for which new drug applications (NDAs) and biologics license applications (BLAs) are expected to be submitted ...