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Home » Topics » Regulatory

Regulatory
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1-8-Amy-Abernethy-FDA.png
CES Digital Health Summit

FDA official looks to take the mystery out of digital regulation

Jan. 8, 2020
By Liz Hollis
LAS VEGAS – The U.S. FDA has said it is looking to help those interested in developing digital health tools, and that commitment took center stage this week during the Digital Health Summit, part of CES 2020. Amy Abernethy, principal deputy commissioner at the FDA, gave an overview of the agency’s thinking on the topic, providing the perspective of someone who came from outside the regulatory world.
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As bushfires continue to burn, Australia’s regulators don’t anticipate delays

Jan. 8, 2020
By Tamra Sami
PERTH, Australia – Although Australia’s deadly bushfires continue to burn, and conditions are expected to worsen later this week as temperatures rise, Australia’s Therapeutic Goods Administration (TGA) is not anticipating any effect on business operations.
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Regulatory front for Jan. 8, 2020

Jan. 8, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Hospital bed, room

Australia implements opioid reforms to deal with 150 hospitalizations per day

Jan. 7, 2020
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration is putting in place a number of opioid reforms to clamp down on the use of opioids to deal with increasing deaths and hospitalizations from the use of those drugs.  
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1-7-Icecure-Medical-multisense-gun.png

FDA OKs new indications for Icecure’s cryoablation technology, new Multisense system

Jan. 7, 2020
By Meg Bryant
Caesarea, Israel-based Icecure Medical Ltd. has won the FDA’s nod for additional indications for its cryoablation technology, paving the way for use in kidney, liver, ear, nose and throat and new neurology indications. The agency also cleared Icecure’s new Multisense system.
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Drug vials and syringe

CDER approval numbers show biosimilar advance, steady pace of novel BLAs

Jan. 7, 2020
By Mari Serebrov
For the first time since Congress opened the door to biosimilars in 2010, the FDA approved nearly as many biosimilars in 2019 as it did new biologics. As the first decade of biosimilars came to a close, the agency’s Center for Drug Evaluation and Research (CDER) approved 10 biosimilars referencing seven blockbuster biologics, bringing the total number of approved biosimilars to 26.
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Regulatory front for Jan. 7, 2020

Jan. 7, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory front for Jan. 7, 2020

Jan. 7, 2020
The latest global regulatory news, changes and updates affecting biopharma.
Read More
Architectural pillars

Regulatory front for Jan. 7, 2020

Jan. 7, 2020
The latest global regulatory news, changes and updates affecting biopharma.
Read More
1-6-Photonicare-TOMiScope.png

New tool could improve diagnosis of middle ear infections

Jan. 6, 2020
By Meg Bryant
Ear infections are a common occurrence in kids, causing pain, fever and, in worst cases, hearing loss. Yet up to half of all cases are misdiagnosed, due to doctors’ inability to look deep into the middle ear where infections reside. Now, the U.S. FDA has cleared the Tomi Scope, a first-in-class technology from Photonicare Inc., of Champaign, Ill., that allows doctors to not only detect the presence or absence of fluid in the middle ear but characterize the type of fluid they see.
Read More
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