NICE, PHE publish antimicrobial prescribing guidance on pneumonia

UK – NICE, PHE publish antimicrobial prescribing guidance on pneumonia

The organisation says that the two guidelines set out an antimicrobial prescribing strategy that aims to optimise antibiotic use and reduce antibiotic resistance. The...
Data submission on authorised medicines (Article 57)

Europe – Data submission on authorised medicines (Article 57)

All holders of marketing authorisations for medicines in the European Union (EU) and the European Economic Area (EEA) must submit information to the European Medicines Agency...
EMA to provide guidance on avoiding nitrosamines in human medicines

Europe – EMA to provide guidance on avoiding nitrosamines in human medicines

EMA’s Executive Director has asked the human medicines committee (CHMP) to provide guidance for avoiding the presence of nitrosamine impurities in human medicines containing...
EMA to review ranitidine medicines following detection of NDMA

Europe – EMA to review ranitidine medicines following detection of NDMA

At the request of the European Commission, EMA is to start a review of ranitidine medicines after tests showed that some of these products...
Study Finds Extent of Unvalidated Surrogate Endpoint Use in Expedited Approvals ‘Concerning’

Europe – Study Finds Extent of Unvalidated Surrogate Endpoint Use in Expedited Approvals ‘Concerning’

Research published this week in PLOS Medicine raises concerns about the use of surrogate endpoints to support the marketing authorizations of products assessed via the European...
When are RCTs Required for Breakthrough Drugs, HDEs? JAMA Study Investigates

USA – When are RCTs Required for Breakthrough Drugs, HDEs? JAMA Study Investigates

A new study in JAMA Network Open finds that drugs and medical devices approved by the US Food and Drug Administration (FDA) based solely on non-randomized...
Novartis Inhaler is First Device to be Certified Under MDR

Europe – Novartis Inhaler is First Device to be Certified Under MDR

BSI’s UK notified body announced Wednesday that the Novartis Concept1 inhaler is the first device to be certified under the new EU Medical Devices...
EC Names New Health Commissioner as Pharmaceutical and Device Units Shift to DG Sante

Europe – EC Names New Health Commissioner as Pharmaceutical and Device Units Shift to...

European Commission President-elect Ursula von der Leyen unveiled her new team of commissioners-designate this week, including the addition of Stella Kyriakides, a medical psychologist from...
Vaccination: European Commission and World Health Organization join forces to promote the benefits of vaccines

Europe – Vaccination: European Commission and World Health Organization join forces to promote the...

Today, the European Commission and the World Health Organization (WHO) are co-hosting the world's first Global Vaccination Summit in Brussels. The aim is to accelerate global...
NICE, PHE publish antimicrobial prescribing guidance on pneumonia

UK – NICE approves BioMarin’s Brineura after initial setback

BioMarin and NICE had a rocky start with Batten disease therapy Brineura, but the two have now come to an agreement.  The positive recommendation of...

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