An app for reporting adverse drug reactions developed by Europe’s Innovative Medicines Initiative is being tested in two African countries, where the mobile infrastructure is said to be more advanced than in EU. The app is expected to help in the collection of ADR data from malaria programs and from general medicines use.
A mobile app for reporting adverse drug reactions (ADRs) developed as part of a project (WEB-RADR) run by the Europe’s Innovative Medicines Initiative is to be tested in March in two African countries – Burkina Faso and Zambia –.
The opportunity to pilot the app in Africa came as a result of WEB-RADR's collaboration with the World Health Organization....
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The European Medicines Agency’s safety committee has concluded that the benefits of medicines containing metamizole continue to outweigh the risks but that new measures are needed to minimize the serious outcomes of agranulocytosis.
Finding the right way to measure outcomes is just one of the difficulties involved in conducting clinical trials of potential new therapies for loss of hearing, which can have a number of different causes.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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