Medical Writing Generics and biosimilars Medical Devices

Volume 28, Issue 2 - Generics and biosimilars

Medical Devices

Abstract

In the last issue, I started to share my opinion on the recently published “implant files”.1,2 As this topic could be discussed endlessly, I focused on an article in a German newspaper, the Süddeutsche Zeitung, that provided a summary about the “10 facts to know about the implant files”.3 In Part 1,2 the first five “facts” were discussed, and this part will focus on the remaining assertions, which are indicated in the subheadings below.

References

  1. Implant files: Health authorities across the globe have failed to protect millions of patients from poorly tested implants, the first-ever global examination of the medical device industry reveals. [cited 2018 Dec 08]. Available at: Available from: https://www.icij.org/ investigations/implant-files/.
  2. Doerr B. The next medical device scandal: medical device files – my personal view (part 1). Med Writ. 2019;28:86–9.
  3. Was Sie über die Implant Files wissen müssen [cited 2018 Dec 08]. Available at: Available from: https://www.sueddeutsche.de/politik/ implant-files-fakten-ueberblick-1.4225363.
  4. ISO14155:2011: Clinical investigation of medical devices for human subjects – Good Clinical Practice [cited 2019 Feb 22]. Available at Available from: https://www.iso.org/standard/ 45557.html.
  5. Physician Payment Sunshine Act. [cited 2018 Dec 30]. Available at Available from: https://en.wikipedia.org/wiki/ PhysicianvPayments_Sunshine_Act.
  6. International Physician Payments Sunshine: EFPIA Code on Transfers of Value and Inconsistencies Within European Member Associations. [cited on 2018 Dec 30]. Available at Available from: https://bit.ly/2R1Qekf.
  7. “Sunshine Act” in Europe: strengthening of transparency obligations for the pharmaceutical and medical device sectors. [cited on 2019 Mar 04]. Available at Available from: http://www.mercure-avocats.com/en/ news/news-detail/sunshine-act-in-europestrengthening- of-transparency-obligationsfor- the-pharmaceutical-and-medical-device -sectors.
  8. The Sun Shines on Europe. Transparency of financial relationships in the healthcare sector. [cited 2019 Mar 04]. Available at Available from: http://haiweb.org/wp-content/uploads/ 2017/03/Sunshine-Act.pdf.
  9. Sunshine Transparency Laws, Regulations and Codes Across Europe [cited on 2019 Mar 04]. Available at Available from: https://mhesme. org/wp-content/uploads/2017/09/ Mapping-of-Sunshine-Laws-in-Europe.pdf
  10. Didier R, Eltchaninoff H, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, et al. Five-year clinical outcome and valve durability after transcatheter aortic valve replacement in high-risk patients. Circulation. 2018;138:2597–607.
  11. Sorajja P, Vemulapalli S, Feldman T, et al. Outcomes with transcatheter mitral valve repair in the United States: An STS/ACC TVT Registry report. J Am Coll Cardiol. 2017;70:2315–27.
  12. Lange R, Beckmann A, Neumann T, et al. Quality of life after transcatheter aortic valve replacement: prospective data from GARY (German Aortic Valve Registry). JACC Cardiovasc Interv. 2016;9:2541–54.
  13. Sarno G, Lagerqvist B, Olivecrona G, et al. Real-life clinical outcomes with everolimus eluting platinum chromium stent with an abluminal biodegradable polymer in patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Catheter Cardiovasc Interv. 2017;90:881–7.
  14. MDR2017/745. [cited on 2019 Jan 01]. Available at Available from: https://ces.to/mmJHhd.
  15. Zeller T, Krankenberg H, Erglis A, et al. A randomized, multi-center, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with hemodynamically relevant atherosclerotic renal artery stenosis (RADAR) – one-year results of a pre-maturely terminated study. Trials. 2017;18:380. doi: 10.1186/s1306.
  16. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597-607.
  17. Medical devices: European Commission calls for immediate actions – tighten controls, increase surveillance, restore confidence. [cited on 2019 Jan 10]. Available at: Available from: http://europa.eu/rapid/pressrelease_ IP-12-119_en.htm
  18. New steps to facilitate beneficial medical device innovation [cited 2019 Jan 11]. Available at: Available from: https://www.fda.gov/ NewsEvents/Newsroom/FDAVoices/ ucm612001.htm.

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Articles

Introduction
James Visanji Tribute
President’s Message
EMWA News
Regulatory pathways for development and submission activities
Biosimilar development – an overview
Statistical principles in biosimilar development
Writing biosimilar clinical study reports and submission documents – what to expect and what to consider
Medical writing for generics throughout the life cycle
Same but different: Basic tools for biosimilar and generic pharmacovigilance writing
Layperson materials in the sphere of biosimilars and generic medicines
Insulin biosimilars
Biosimilars: Change, challenge, and accomplishments
ICMJE requirements for sharing individual participant data from interventional clinical trials
Medicinal products and medical devices in clinical trials conduct and disclosure
Publication of clinical trial protocols and statistical analysis plans on ClinicalTrials.gov
Collecting metrics in medical writing – the benefits to you and your business
Document management systems for medical writing
Winner of the Geoff Hall Scholarship Essay Competition
Regulatory Matters
News from the EMA
Getting Your Foot in the Door
Veterinary Medical Writing
Teaching Medical Writing
Medical Devices
My First Medical Writing
Journal Watch
Good Writing Practice
Regulatory Public Disclosure
Out on Our Own

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Raquel Billiones

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Evguenia Alechine

Jonathan Pitt

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Victoria White

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Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Joselita T. Salita

Amy Whereat

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Nicole Bezuidenhout 

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Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Raquel Billiones

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Jennifer Clemens

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Karim Montasser

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk