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Home » Topics » Regulatory

Regulatory
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Court says PTAB appointment process is unconstitutional

Nov. 4, 2019
By Mark McCarty
The U.S. Court of Appeals for the Federal Circuit has decreed that the regulations governing appointment of judges to the Patent Trial and Appeal Board (PTAB) violate the U.S. Constitution – a decision that gives a medical device maker a new bite at patent litigation, but which also raises the question of whether a large number of PTAB decisions will have to be relitigated.
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FDA gives nod to Xact's robotic system for percutaneous interventional procedures

Nov. 4, 2019
By Liz Hollis
Robotics has been a hot topic over the last year or so, from product unveilings to M&A. Now, Xact Robotics Ltd., which has a presence in Hingham, Mass., and Caesarea, Israel, has reported that its first robotic system gained clearance in the U.S. for use during computed tomography-guided percutaneous interventional procedures.
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Regulatory front for Nov. 1, 2019

Nov. 1, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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Agile shares climb after adcom emphasizes patient choice in backing Twirla

Nov. 1, 2019
By Michael Fitzhugh
Shares of Agile Therapeutics Inc. (NASDAQ:AGRX) trebled Thursday, rising 223.8% to $1.20 at the market's close following a near-unanimous FDA adcom vote the day before supporting approval for the company's transdermal contraceptive patch, Twirla (levonorgestrel/ethinyl estradiol). 
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Regulatory front for Nov. 1, 2019

Nov. 1, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Indonesia formalizes medical device risk registration system for ASEAN harmonization

Nov. 1, 2019
By David Ho
HONG KONG – Indonesian regulators have introduced a medical device risk classification system, as part of a harmonization of regulations across the Association of Southeast Asian Nations (ASEAN) region. The 'Sistem Klasifikasi Risiko Alat Kesehatan' system, known by the acronym Siklara, takes its cues from the ASEAN Medical Device Directive (AMDD).
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'Clerical errors' common trigger for rejected special 510(k)s

Nov. 1, 2019
By Mark McCarty
The U.S. FDA's overhaul of the 510(k) program continues apace with the recent final guidance for the special 510(k) mechanism. However, a member of the FDA staff said clerical errors account for a conspicuous number of conversions of these applications to traditional 510(k)s than any other problem. The agency posted the final guidance for the special 510(k) program in September with features seen in the draft that drew opposition from device makers.
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FDA approves Vumerity for the treatment of multiple sclerosis

Oct. 31, 2019

Regulatory front for Oct. 31, 2019

Oct. 31, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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Agile Twirla'ing following FDA adcom vote based on choice

Oct. 31, 2019
By Mari Serebrov
Agile Therapeutics Inc. didn't feel much love Wednesday from FDA reviewers who questioned the efficacy of its Twirla birth control patch, but it got a warm embrace from the Bone, Reproductive and Urologic Drugs Advisory Committee, which voted 14-1, with one abstention, that Twirla's benefits outweigh its risks.
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