Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 – 12...
Review of hydroxyprogesterone started
EMA has started a review of medicines containing hydroxyprogesterone following concerns about the safety and effectiveness of these medicines. In the...
Europe – Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling...
EMA’s safety committee, PRAC, is reminding healthcare professionals that the use of fluoroquinolone antibiotics, given by mouth, injection or inhalation, is restricted due to the...
UK – Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master...
The following legal obligations apply to holders of UK marketing authorisations (MA). These include those that cover the whole of the UK, or are...
USA – FDA wants feedback on testing methods for new nitrosamines
The US Food and Drug Administration (FDA) is requesting stakeholder input on approaches for identifying and testing novel nitrosamines identified in drug products and...
France – Anti-inflammatoires non stéroïdiens (AINS) et complications infectieuses graves
Les AINS, tels que l’ibuprofène, le kétoprofène, sont parmi les médicaments les plus utilisés en automédication comme antalgiques (anti-douleurs) ou antipyrétiques (anti-fièvre) chez les...
UK – Otsuka’s Lupkynis receives NICE green light
Recommendation applies across England and Wales and the treatment is available now
Otsuka Pharmaceuticals has revealed that the National Institute for Health and Care Excellence...
Europe – Review of transparency rules for the EU Clinical Trials Information System (CTIS)
EMA has opened a public consultation to review the transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union...
Canada – Guidance : Nitrosamine impurities in medications
This guidance represents Health Canada's current thinking and recommendations on issues related to N-nitrosamine impurities (nitrosamine impurities or nitrosamines). This guidance may be subject to...
USA – FDA issues draft guidance on decentralized clinical trials
In a newly released draft guidance, the US Food and Drug Administration (FDA) is proposing recommendations on conducting decentralized clinical trials (DCTs) of drugs,...
Europe – GSK’s RSV vaccine candidate recommended by CHMP for older adults
There are currently no vaccines available to help protect older adults from RSV, a common contagious virus characterised by several mild, cold-like symptoms. Although...
