USA – FDA final guidance targets neonatal pharmacology studies
The US Food and Drug Administration (FDA) issued final guidance this week to assist sponsors in developing clinical pharmacology studies for neonatal populations. The guidance is...
USA – FDA final guidance clarifies whole slide imaging expectations in nonclinical toxicology studies
The US Food and Drug Administration (FDA) on Tuesday issued final guidance on the use of whole slide imaging in nonclinical toxicology studies. The...
International – ICH charts new topics, touts progress in updating existing guidelines
The International Council for Harmonisation (ICH) announced plans to work on three new topics this year covering patient preference studies, non-clinical safety studies for...
Europe – Actions to support the development of medicines for children
Regulators in the European Union (EU) have taken several initiatives in the past four years to increase the efficiency of paediatric regulatory processes and...
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...
Suisse – Swissmedic updates guidance on temporary medicine authorization to harmonize deadlines
The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance on the temporary authorization of human medicinal products.
In the document, Swissmedic outlines the...
USA – FDA finalizes PK-based dosing guidance for PD-1/PD-L1 inhibitors
The US Food and Drug Administration (FDA) this week finalized guidance detailing how sponsors of programmed cell death receptor-1 (PD-1) and programmed cell death-ligand...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
10 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its October 2022 meeting.
The CHMP recommended granting a marketing authorisation for Dengue Tetravalent...
France – Covid-19 : la HAS élargit l’autorisation d’accès précoce accordée à Evusheld®
Le 9 décembre 2021, la Haute Autorité de santé (HAS) autorisait l’accès précoce à Evusheld® (association de deux anticorps monoclonaux, tixagévimab et cilgavimab) en...
Europe – Global regulators strengthen efforts to ensure continuous availability of safe and high-quality...
On 20 July 2023, a virtual workshop was held to discuss progress made in the development of a PQ KMS. The workshop was jointly organised by...
