UK – MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation...
A series of new measures will be introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) with support from partners to make it faster...
International – ICH adopts S12 guideline for gene therapies
The International Council for Harmonisation (ICH) last week announced that its S12 guideline on nonclinical biodistribution (BD) considerations for gene therapy products has reached...
UK – MHRA to recognize foreign regulatory approvals for medicines and medical technologies and...
Last week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK. It identified life sciences and digital technologies as “high...
USA – Advanced manufacturing: GAO, USP reports say regulatory enhancements needed
The Government Accountability Office (GAO) and the United States Pharmacopeia (USP) asserted in two recent reports that the regulators need to address some of...
France – Risque de méningiome et progestatifs : recommandations générales pour limiter ce risque
Les progestatifs sont des médicaments utilisés dans diverses pathologies gynécologiques (endométriose, fibromes, règles particulièrement longues et/ou abondantes, troubles du cycle), dans le traitement hormonal...
USA – Industry requests more information from FDA on dosage and administration labeling
While the US Food and Drug Administration’s (FDA) latest draft guidance on improving the consistency of information in the dosage and administration section of...
USA – FDA finalizes guidance on suspect products under DSCSA
The US Food and Administrations (FDA) on Thursday finalized guidance defining what constitutes suspect and illegitimate products, as well as what constitutes products that...
USA – FDA issues guidance on developing long-acting local anesthetics
The US Food and Drug Administration (FDA) has issued draft guidance on the development of local anesthetic products with a prolonged duration of effect...
UK – NICE approves funding for Novartis gene therapy
NICE has published final draft guidance regarding the recommendation of routine NHS funding for onasemnogene abeparvovec.
The treatment is a potentially curative one-off gene therapy...
USA – Pharma wants FDA’s IND reporting rule better aligned with ICH E2F
Pharmaceutical industry stakeholders urged the US Food and Drug Administration (FDA) to better align its investigational new drug application (IND) annual reporting proposal with...
