France – Essais cliniques de médicaments : toutes les demandes de transition doivent être...
Le REC est entré en vigueur le 31 janvier 2022. Il a remplacé la directive 2001/20/CE (transposée en France dans la loi Jardé).
Depuis cette...
Europe – Human medicines: highlights of 2023
The Agency recommended two vaccines to protect against lower respiratory tract disease caused by respiratory syncytial virus (RSV), and the first advanced therapy medicinal product using...
Switzerland – Swissmedic updates guidances on API, fast-track pathway, and more
Swissmedic has made updates to several of guidances related to active pharmaceutical ingredients (API), temporary authorization, products that receive fast-track authorization, and other documents...
UK – Pfizer’s COVID-19 antiviral Paxlovid recommended by NICE for expanded use
A further 1.4 million people with an increased risk for progression to severe COVID-19 will be eligible for Paxlovid following a positive test.
NICE already recommends the...
Europe – Potential risk of neurodevelopmental disorders in children born to men treated with...
EMA’s safety committee (PRAC) is recommending precautionary measures for the treatment of male patients with valproate medicines. These measures are to address a potential...
USA – FDA updates draft guidance on division-level ANDA disputes
The US Food and Drug Administration (FDA) has published an updated draft guidance explaining how generic drug sponsors can ask for reconsideration of a...
Europe – EMA explains how tweaked Brexit deal will affect medicinal products
The European Medicines Agency (EMA) has answered nine questions on how the revised Brexit rules apply to centrally authorized medicinal products for human use...
USA – FDA issues final guidance on rare disease drug development
The US Food and Drug Administration (FDA) finalized guidance on drug development programs for rare diseases, eliminating a section on natural history and providing...
International – WHO decision improves children’s access to safer polio vaccine
Three years after it received its Emergency Use Listing (EUL) and with 950 million doses now delivered worldwide, nOPV2 has been prequalified by the WHO,...
USA – Novel Drug Approvals for 2023
Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When it comes the development of...
