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The US Food and Drug Administration (FDA) has issued draft guidance on the development of local anesthetic products with a prolonged duration of effect...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NICE has published final draft guidance regarding the recommendation of routine NHS funding for onasemnogene abeparvovec.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...
USA – FDA revises guidance on electronic systems and signatures in clinical trials
The US Food and Drug Administration (FDA) on Wednesday revised its draft guidance on electronic systems, records and signatures in clinical trials. While the...
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...
International – EMA-FDA parallel scientific advice program has ‘limited’ uptake
A review of the last five years of the Parallel Scientific Advice (PSA) program between the US Food and Drug Administration (FDA) and the...
USA – FDA warns pharmacy benefit company for distributing unapproved foreign drugs
The US Food and Drug Administration (FDA) recently warned pharmacy benefit firm ElectRx for substituting prescription drugs ordered by its customers with drugs sourced...
International – Bébé-Crispr : la modification du génome d’embryon bute sur des obstacles techniques
Une décennie après son déferlement dans les laboratoires, l’outil de modification du génome Crispr-Cas9 alimente toujours une révolution scientifique et médicale et continue de...
UK – Pholcodine-containing cough and cold medicines: withdrawal from UK market as a precautionary...
Pholcodine-containing cough and cold medicines are being withdrawn from the UK market as a precaution following a review which found that their benefits...
USA – FDA approves first treatment for Rett Syndrome
FDA has approved Daybue (trofinetide) oral solution as the first treatment for Rett syndrome, a rare, genetic neurological disorder. Daybue is approved for the...
