USA – FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary...
As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide...
USA – FDA updates guidance on remote regulatory assessments
The US Food and Drug Administration (FDA) has revised its draft guidance on remote regulatory assessments (RRAs), outlining how it plans to use both...
Europe – Precautionary measures to address potential risk of neurodevelopmental disorders in children born...
On 24 January 2024, the CMDh1 endorsed precautionary measures recommended by EMA’s safety committee (PRAC) for the treatment of male patients with valproate medicines. These measures...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Three new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.
The committee recommended granting a marketing...
Europe – EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine...
This medicine is used for treating patients with Duchenne muscular dystrophy whose disease is caused by a type of genetic defect called a ‘nonsense...
Europe – EMA confirms measures to minimise the risk of serious side effects with...
PRES and RCVS are rare conditions that can involve reduced blood supply to the brain, potentially causing serious, life-threatening complications. With prompt diagnosis and...
USA – FDA final guidances aim to streamline ANDA reviews
The US Food and Drug Administration (FDA) has published two final guidances for generic drug sponsors that the agency says will streamline the premarket...
UK – NICE recommends two AI-powered software tools for stroke diagnosis in NHS
The two softwares – e-Stroke and RapidAI – were selected after the health technology assessment agency found some evidence of faster and better access...
International – ICH Q14 Analytical procedure development – Scientific guideline
This guideline describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the assessment of the quality of drug substances and drug products....
International – ICH Q2(R2) Validation of analytical procedures – Scientific guideline
This guideline presents a discussion of elements for consideration during the validation of analytical procedures included as part of registration applications submitted within the ICH member regulatory authorities. It provides...
