Medical Writing Medical Devices News from the EMA

Volume 26, Issue 2 - Medical Devices

News from the EMA

Abstract

Conditional marketing authorisations give patients access to important new medicines earlier

January 23, 2017 – Conditional marketing authorisation (CMA) can speed up access to medicines for patients with unmet medical needs in the European Union (EU). It allows the authorisation of medicines if the public health benefit of their immediate availability to patients outweighs the risk of an authorisation on the basis of less comprehensive data than normally required. The European Medicines Agency (EMA) has published a report on the CMA experience based on the data collected over 10 years since 2006. Since 2006, a total of 30 medicines have received a CMA. Over this 10- year period, no medicine with a CMA had to be revoked or suspended. Medicines that were granted a CMA target seriously debilitating or life-threatening conditions such as HIV infection, breast cancer, severe epilepsy in infants, or multi-drug resistant tuberculosis. Fourteen were orphan medicines, providing patients suffering from rare diseases with new therapeutic options.

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Articles

Medical Devices: An exciting industry at a crossroads
President's Message
EMWA News
Writing for medical devices compared to pharmaceuticals: An introduction
Clinical Evaluation Reports from the medical writer’s perspective!
New EU medical device regulations: Impact on the MedTech sector
Medical Device Regulation: A necessary step towards more patient and user safety
Transparency – left to its own devices until now
Medical devices in the disclosure era and the role of medical writers
Does standardisation improve animal testing of medical devices?
Puns, promises, and metaphors: Medical device trade names
French breast implants, the Medical Device Regulation, and a theoretical case study
Science journalism: In search of a new identity
Can a medical writer submit a manuscript on behalf of a corresponding author?
To be or not to be – Are medical and scientific writers of non-native English origin at a disadvantage?
Winners of the Geoff Hall Scholarship Essay Competition
Good medical writing saves lives: The perspective of a former medic
Good medical writing saves lives – and even a little comma can make a difference
Abstracts from 44th EMWA conference Poster session
News from the EMA
Journal Watch
Gained in Translation
Getting Your Foot in the Door
In the Bookstores
Regulatory Matters
The Webscout
Good Writing Practice
Profile
Out on Our Own

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Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Joselita T. Salita

Amy Whereat

Section Editors

Nicole Bezuidenhout 

Digital Communication

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