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...
Europe – User guide for micro, small and medium-sized enterprises
This guide has been prepared for micro, small and medium sized enterprises (‘SMEs’) operating in the pharmaceutical sector. Its aim is to facilitate understanding...
USA – Growing interest in modeling prompts launch of MIE program for generic drugs
Officials from the US Food and Drug Administration (FDA) explained how sponsors can increase their chances of getting accepted into the new model-integrated evidence...
UK – MHRA introduces new restrictions for fluoroquinolone antibiotics
From today, fluoroquinolone antibiotics given systemically (by mouth, injection, or inhalation) must only be administered when no other antibiotics are appropriate for use, the Medicines...
UK – Pfizer’s Talzenna recommended by NICE for advanced breast cancer
Patients eligible for the PARP inhibitor will have previously been treated with anthracycline or taxane chemotherapy, or both, unless these treatments are not suitable.
Additionally,...
