To say a lot is riding on the Nov. 3 presidential and congressional election in the U.S. would be an understatement, as the outcome could impact drug pricing, patent reform, research spending and pandemic response and preparedness.
When entrepreneurs and emerging businesses raise seed capital for a new business or generate funding for business growth, they often turn to the exempt offering framework under the Securities Act. However, when doing so, they are faced with a confusing and complex system that must be navigated. To simplify the process, the SEC has announced that it is amending its rules that govern offering exemptions, which small and medium-sized business rely on to raise capital.
Patient perspectives on medical device development are becoming much more central to the U.S. FDA’s regulation of devices, thus the August 2020 draft guidance for selection of patient-reported outcome instruments for device evaluation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomarin, Chemocentryx, Emmaus, Engene, Enlivex, Galapagos, Gensight, Gilead, Nanomab, Vifor Fresenius.
Boston Scientific Corp. has scooped up an approval from the U.S. FDA for the Ranger drug-coated balloon to help those with peripheral artery disease in the superficial femoral artery and proximal popliteal artery.
Patient perspectives on medical device development are becoming much more central to the U.S. FDA’s regulation of devices, thus the August 2020 draft guidance for selection of patient-reported outcome (PRO) instruments for device evaluation. However, the draft is sufficiently vague on the question of when an existing PRO can be tweaked without an entirely new validation study to prompt the Advanced Medical Technology Association (Advamed) to press the agency for more clarity on that point.
PERTH, Australia – With the approval of cystic fibrosis treatment Bronchitol (mannitol), Sydney-based Pharmaxis Ltd. joins a small group of elite Australian biotech companies to take their drugs all the way to FDA approval.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS announces testing agreements; TGA slaps two companies for violations.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Brighter.
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