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BioWorld - Tuesday, February 17, 2026
Home » Topics » Regulatory

Regulatory
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FDA approves Erleada for metastatic castration-sensitive prostate cancer

Sep. 18, 2019

Stakeholders resistant to participation mandate in radiation oncology APM

Sep. 18, 2019
By Mark McCarty
The Medicare radiation oncology alternative payment model is yet another attempt to control Medicare spending growth, but provider groups and device makers oppose mandatory program participation. Varian Medical offered a blistering critique of the participation mandate, stating that the participation mandate suggests that the U.S. Centers for Medicare and Medicaid Services (CMS) is less interested in a valid test of the program than it is in generating immediate savings.
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Regulatory front

Sep. 18, 2019

Product regulatory actions for Sept. 17, 2019

Sep. 18, 2019

Dreamed wins U.S. and EU approval for AI-based insulin recommendation technology

Sep. 18, 2019
By David Ho
HONG KONG – Dreamed Diabetes Ltd., of Petah Tikva, Israel, has received both FDA clearance and the CE mark for an insulin dosing decision support software based on artificial intelligence (AI).
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Regulatory front

Sep. 17, 2019

Product regulatory actions for Sept. 16, 2019

Sep. 17, 2019

Gala Therapeutics gets breakthrough device designation for Rheox system

Sep. 17, 2019
By Liz Hollis
Chronic bronchitis affects more than 9 million people in the U.S., but current treatments fail to address the overproduction of mucus. Gala Therapeutics Inc., of Menlo Park, Calif., is looking to change that.
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Australia proposes revising device essential principles to align with international practices

Sep. 17, 2019
By Tamra Sami
PERTH, Australia – The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal that to change Australia's medical device essential principles for safety and performance to more closely mirror the new EU Medical Device Regulation (EU MDR).
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FDA advisory committee suggests disclosure of cybersecurity risks should be only to patients

Sep. 17, 2019
By Mark McCarty
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