USA – FDA drafts guidance on multiregional clinical trials in oncology
In a new draft guidance, the US Food and Drug Administration (FDA) provided recommendations for multiregional clinical trials (MRCTs) in oncology, encouraging sponsors to...
USA – FDA updates guidance on classifying ANDA amendments for GDUFA III
The US Food and Drug Administration (FDA) on Thursday issued updated guidance on the classification of amendments to abbreviated new drug applications (ANDAs) or...
Europe – EMA updates guideline on developing drugs for bipolar disorder
The European Medicines Agency (EMA) on 9 September proposes updating its guideline on developing drugs for treating bipolar disorder (BD) to reflect new medical...
USA – FDA revises final guidance on nitrosamine impurities
The US Food and Drug Administration (FDA) on Wednesday issued a revised final guidance to assist manufacturers in detecting and controlling nitrosamine impurities in...
International – The ICH E11A Guideline reaches Step 4 of the ICH Process
The E11A Guideline provides recommendations and promotes international harmonisation of paediatric extrapolation to support the development and authorisation of paediatric medicines. The E11A Guideline
provides...
UK – Relugolix for treating hormone-sensitive prostate cancer
The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health...
UK – Emergency kits for people with adrenal insufficiency recommended to avoid hospital admission
The kits would be used help those with primary or secondary adrenal insufficiency to treat and avoid an adrenal crisis and the need to...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2024
EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole
Product information to be updated to raise awareness of known risk of...
UK – MSD’s Welireg recommended by NICE to treat rare von Hippel-Lindau disease
The take-at-home tablet will be available on the NHS in England and Wales to treat von Hippel-Lindau (VHL) disease in adults who require therapy...
UK – Novartis’ Fabhalta recommended by NICE to treat rare blood disorder PNH
The factor B inhibitor will be available immediately on the NHS in England and Wales to treat patients with the rare blood disorder that...
