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Three Candidates in Running to Become FDA Commissioner, Including Acting Chief Ned Sharpless

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Three Candidates in Running to Become FDA Commissioner, Including Acting Chief Ned Sharpless September 16, 2019 Issue 161 Three Candidates In Running To Become FDA Commissioner, Including Acting Chief Ned Sharpless SUE DARCEY [email protected] hile four former FDA com- von Eschenbach (2006-2009) and Mark Photo credit: M.D. Anderson Cancer Center Center Cancer Anderson M.D. credit: Photo missioners on 3 September McClellan (2002-2004) praised acting com- STEPHEN HAHN endorsed Ned Sharpless, the missioner Sharpless’ “ability to execute the W MD Anderson Cancer Center oncologist agency’s acting commissioner, to be the critical and complex work of the agency.” Trump administration’s permanent choice The former commissioners said in the to lead the agency, an MD Anderson Can- letter that “it is imperative that FDA have a cer Center oncologist or Harvard Univer- permanent leader,” as the agency regulates sity dermatologist may also be chosen. a quarter of products consumed in the US, Besides Sharpless, the other two candi- “including lifesaving therapies and the na- dates being considered to lead the FDA tion’s food supply.” The former commis- are Harvard University dermatology pro- sioners added that on a permanent basis, fessor Alexa Boer Kimball and MD Ander- “Sharpless’ expertise will enable new ac- son Cancer Center radiation oncologist tivities in such key areas as cancer treatment Stephen Hahn. and prevention, and precision medicine.” Harvard University credit: Photo Sharpless became acting commis- Gottlieb, who also has been an enthu- ALEXANDRA “ALEXA” BOER KIMBALL sioner on 8 April when former FDA chief siastic backer of Sharpless for the perma- Harvard University dermatologist Scott Gottlieb stepped down from the nent post, was prevented from signing post to end a long weekly commute be- onto the 3 September letter due to post- tween Washington, DC, and his Westport, FDA employment restrictions preventing CT, home. Sharpless previously served him from contacting federal health offi- as director of the National Institutes of cials, he told Medtech Insight’s sister pub- Health National Cancer Institute (NCI). lication The Pink Sheet. (Also see "Former (Also see "NCI Director And Former Dx Commissioners Push For Sharpless Nomina- Start-Up Founder Sharpless Will Helm FDA" tion, Confirmation" - Pink Sheet, 4 Sep, 2019.) - Medtech Insight, 12 Mar, 2019.) In their letter to President Trump and KIMBALL IS CHAMPION OF US Department of Health and Human EXPANDED PATIENT ACCESS archives Informa credit: Photo Services secretary Alex Azar, former FDA Alexandra Boer Kimball, who goes by NORMAN “NED” SHARPLESS commissioners Robert Califf (2016-2017), “Alexa,” is a respected clinician, re- Current acting FDA commissioner Margaret Hamburg (2009-2015), Andrew CONTINUED ON PAGE 5 FOR THE LATEST INSIGHT ON THE MEDTECH INDUSTRY VISIT: MEDTECH.PHARMAINTELLIGENCE.INFORMA.COM POLICY & REGULATION COMMERCIAL R&D Final guidance clarifies HDE process, Intuitive Surgical opens new Abbott launches TriClip pivotal trial in “probable benefit,” p. 9 UK/Ireland HQ in Oxfordshire, p. 18 the US, p. 22 Book your table Medtech Insight Awards 2019 Monday, September 23, 2019 | State Room, Boston https://pharmaintelligence.informa.com/mti_awards2019 SPONSORSHIP AND TABLE BOOKING ENQUIRIES: Christopher Keeling T: +44 (0) 20 3377 3183 E: [email protected] GENERAL ENQUIRIES: Jo Kirkpatrick T: +44 (0) 20 7017 7180 E: [email protected] Headline Sponsor In partnership with JN2412 Medtech Awards 2019 Book your Table Advert US Letter.indd 1 2019/08/12 15:35 8 10 16 Book your table explore more: inside: Cover / Three Candidates In Running To Become FDA Medtech Insight exclusive online content Commissioner, Including Acting Chief Ned Sharpless ResMed’s 2025 strategy EDITORS’ PICKS http://bit.ly/2mc98q9 5 Device Sterilization, Duodenoscopes Focus Of Planned In an interview with Medtech Insight, ResMed CEO Mick Meeting – US hospitals would have to reveal their standard Farrell outlined the company's 2025 strategy: double-digit charges and insurer-negotiated prices for a long list of Awards 2019 growth, drive the user base to 250 million people and procedures and lab tests under a new proposed rule. become the leading digital health company in both sleep apnea and chronic obstructive pulmonary disease. 6 New FDA Guidance Expands HUD Patient Limit – Devices to treat diseases and conditions affecting many more De novo guidance Americans are eligible for Humanitarian Use Device status http://bit.ly/2kfgOaw under a new guidance document. The US FDA published a final guidance that goes into 6 UK’s Own Medtech Regs: Political Turmoil Could Make Monday, September 23, 2019 | State Room, Boston effect in early October that lists items sponsors should November Deadline Redundant – Brexit-related dates are submit when filing a de novo application. https://pharmaintelligence.informa.com/mti_awards2019 up in the air for the UK. Reimbursement in Turkey POLICY & REGULATION http://bit.ly/2kuMrgw 7 Australia To Improve Compliance For Device Systems After recent intervention from the medical device industry, and Procedure Packs – The Therapeutic Goods the Turkish government has finally done something Administration is seeking feedback on proposals affecting to address calls for systematic and comprehensive manufacturers of packages containing therapeutic goods. SPONSORSHIP AND TABLE BOOKING ENQUIRIES: improvement of medtech reimbursement prices. Christopher Keeling 8 Danish Regulator Offering Free Advice On How to Dreem 2 launched T: +44 (0) 20 3377 3183 Comply With New EU Regulations – The Danish Medicines http://bit.ly/2lIknqb E: [email protected] Agency is testing a new regulatory advice service for Dreem 2 is Dreem’s newest biofeedback headband with medical device SMEs. seven sensors that measure brain activity, heart rate, GENERAL ENQUIRIES: respiration and movement that works with a mobile app 9 Final Guidance Clarifies HDE Process, ‘Probable Benefit’ – Jo Kirkpatrick to help users improve the quality of their sleep. The US FDA has finalized a guidance document on the humanitarian device exemption process. T: +44 (0) 20 7017 7180 Execs On The Move E: [email protected] http://bit.ly/2kfhkW0 9 FDA’s Quality System Regulation Is Mapped To ISO Headline Sponsor CFO of neurovascular device-maker Penumbra adds 13485 In New Report From AAMI – A new Technical president title to job description; PerkinElmer promotes Information Report from the Association for the COO to CEO; chronic liver disease management company Advancement of Medical Instrumentation compares Echosens poaches AxoGen exec for North America CEO regulatory requirements found in the US FDA’s QSR quality spot; and more. systems standard ISO 13485:2016. In partnership with 10 Policy Experts Predict Minor Changes To HHS Price medtech.pharmaintelligence.informa.com Transparency Rule – Health policy predict the US HHS will require hospitals and insurers to display typical procedure prices. medtech.pharmaintelligence.informa.com September 16, 2019 | Medtech Insight | 3 JN2412 Medtech Awards 2019 Book your Table Advert US Letter.indd 1 2019/08/12 15:35 14 Rep. Shimkus, Author Of ‘Cures’ Device Provisions, Joins Exodus Of House Republicans – Illinois Rep. John Shimkus, a well-known pro-medtech industry bill sponsor, SHAWN M. SCHMITT @MEDTECHSHAWN announced on 30 August joins at least 15 Republican House [email protected] members who have announced their departure. REED MILLER @MEDTECHREED [email protected] 15 So You Think You Want to Work At A Notified Body? – In AMANDA MAXWELL @MEDTECHAMANDA an interview with Medtech Insight, Elena Kyria, founder of [email protected] UK-based recruiting firm Elemed, explained what is driving MARION WEBB @MEDTECHMARION notified body-related recruitment moves and what to expect. [email protected] SUE DARCEY @MEDTECH_INSIGHT 16 AI Focus At NHSX Lets Clinicians ‘Function At The Top Of [email protected] Their License’ – Less than 2% of NHS England’s budget is FERDOUS AL-FARUQUE @MEDTECH_DANNY spent on digital technology, NHS chief information officer [email protected] Simon Eccles told delegates at the NHS Health and Care ELIZABETH ORR @ELIZABETHJORR Innovation Expo. [email protected] COMMERCIAL CATHERINE LONGWORTH @MEDTECHCATE [email protected] 18 Intuitive Surgical Opens New UK/Ireland HQ In Oxfordshire – Surgical robotics giant Intuitive Surgical has opened a new ASHLEY YEO @ASHLEYPYEO [email protected] UK and Ireland headquarters and training suite in Oxford. MAUREEN KENNY @SCRIPREGMAUREEN 19 Stryker Closes Gap With Competitors In Strategic Spinal [email protected] Robotics Acquisition – Stryker is acquiring Mobius Imaging NEENA BRIZMOHUN @SCRIPREGNEENA and spine Cardan Robotics in a deal worth up to $500m. [email protected] VIBHA SHARMA @SCRIPREGVIBHA 19 FDA Approves Axonics’ Neuromodulation Device [email protected] For Incontinence – The US FDA has approved r-SNM ANDREA CHARLES CUSTOM CONTENT sacral neuromodulation system for treating chronic fecal [email protected] incontinence. JANET HANIAK SENIOR DESIGNER 20 Molecular Diagnostic Firms Curetis And OpGen Announce GAYLE REMBOLD FURBERT HEAD OF PUBLICATION DESIGN Merger – The combination of the molecular diagnostic RICHARD FAINT HEAD OF MEDTECH companies is structured as an acquisition of Curetis by OpGen. [email protected] PHIL JARVIS MANAGING DIRECTOR 21 Verily And iRhythm Agree To Collaborate On Atrial TO SUBSCRIBE, VISIT Fibrillation – Verily Life Sciences and iRhythm
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