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BioWorld - Tuesday, April 28, 2026
Home » Topics » Regulatory

Regulatory
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China three-year plan aims to put patient access to cancer drugs on par with other markets

Oct. 2, 2019
By Elise Mak
SUZHOU, China – Under the "Healthy China" campaign, China has introduced a three-year action plan for preventing and treating cancer. The plan vows to speed up the marketing of cancer drugs in the country, even aiming for simultaneous marketing with other countries.
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FDA approves Invokana for use in patients with type 2 diabetes and diabetic kidney disease

Oct. 1, 2019

FDA approves Rituxan for pediatric granulomatosis with polyangiitis and microscopic polyangiitis

Sep. 30, 2019

FDA sorts out regulated, non-regulated decision support apps in new draft

Sep. 30, 2019
By Mark McCarty
The FDA has reissued a 2017 draft guidance for clinical decision support (CDS) applications as part of a reexamination of software regulations, and one difference between the 2017 draft and the latest iteration that is sure to cheer developers is that the agency now provides much more clarity as to the types of functions that will and will not fall under regulatory scrutiny going forward.
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Bracing for possible crash-out Brexit, BIA, government continue urging preparedness

Sep. 30, 2019
By Nuala Moran

FDA approves Jynneos for prevention of smallpox and monkeypox disease in adults

Sep. 27, 2019

Regulatory front

Sep. 27, 2019

Shuren cites need for flexibility, says regulatory Legos the prescription

Sep. 27, 2019
By Mark McCarty
BOSTON – The 2019 Medtech Conference included the annual FDA town hall session, and Jeff Shuren, director of the agency's device center, said the pace of scientific change is outstripping the agency's ability to keep up. Shuren said the solution might be "regulatory Legos," an approach that might eliminate the need to go to Congress for new statutory authorities every time device makers carve open a new technological frontier.
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Industry warns Labour's plan to cut drug prices would discourage U.K. innovation

Sep. 26, 2019
By Nuala Moran
LONDON – The industry has hit out at a proposal by the U.K.'s opposition Labour party to create a state-owned generic drugs company to supply the National Health Service and to force companies to cut the cost of expensive proprietary products.
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Politics overriding congressional Rx pricing fix

Sep. 26, 2019
By Mari Serebrov
Wednesday's House subcommittee hearing on H.R. 3, which tasks Medicare with directly negotiating prescription drug prices in the U.S., may have been an exercise in futility. Although both Republicans and Democrats in Congress still agree that something has to be done to lower drug prices, they are beyond compromise on key aspects of H.R. 3, the Lower Drug Costs Now Act.
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