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Home » Topics » Regulatory

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Architectural pillars

Regulatory front for April 7, 2020

April 7, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Biotechnology Innovation Organization, Central Drugs Laboratory, Drugs Controller General, EMA, FDA, Gilead Sciences, Health and Human Services, Medicines and Healthcare Products Regulatory Agency, National Institute for Health and Care Excellence, Pfizer Healthcare India, Pharmaceuticals and Medical Devices Agency.
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Regulatory actions for April 7, 2020

April 7, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cochlear, Genetron, Gnomegen, Motus GI, Nitiloop, Orthosensor.
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Regulatory front for April 7, 2020

April 7, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3M, Boston Scientific, Gnomogen, Viracor Eurofins Clinical Diagnostics.
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Regulatory actions for April 7, 2020

April 7, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agenus, Alnylam, Ascentage, Blaze, Immunomedics, Merck.
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olympus-meditate-itind.png

FDA gives de novo nod to Itind for benign prostatic hyperplasia

April 6, 2020
By Meg Bryant
Olympus Medical Systems Group, of Center Valley, Pa., a division of Olympus Corp., is preparing the U.S. launch of the Itind device for the treatment of benign prostatic hyperplasia (BPH), following FDA de novo authorization earlier this year. The nonsurgical, minimally invasive treatment is made by Medi-Tate Ltd., of Or-Akiva, Israel.
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Axonics-r-snm-11-18.jpg

Axonics looks to expand reach with its r-SNM system

April 6, 2020
By Liz Hollis
Irvine, Calif.-based Axonics Modulation Technologies Inc., which is marketing implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, reported the submission of a premarket approval (PMA) supplement. Specifically, it is looking to gain full-body magnetic resonance imaging-conditional labeling for 3.0 Tesla (T) MRI scans.
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Regulatory front for April 6, 2020

April 6, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Mimedx.
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Regulatory actions for April 6, 2020

April 6, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medi-Tate, Merit Medical, Olympus.
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Regulatory actions for April 6, 2020

April 6, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acceleron, BMS, Daiichi, Eisai, GW, Histogen, Hope, Mallinckrodt, Mateon, Mesoblast, Novo Nordisk, Takeda, Tetra, Tracon.
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Regulatory front for April 6, 2020

April 6, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Gilead.
Read More
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