USA – OIG raises concerns about accelerated approval pathway
More than one-third of accelerated approval applications do not meet their original confirmatory trial dates, and four drug applications were more than 5 years...
UK – European Commission Decision Reliance Procedure (EC DRP) extension
European Commission Decision Reliance Procedure has been extended by 12 months to apply across Great Britain until 31 December 2023, to ensure British people...
USA – Remote regulatory assessments: Pharma, device groups want more details on FDA guidance
Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of remote regulatory assessments (RRAs) as outlined in the US...
International – WHO reports warnings of ‘COVID-19 complacency’ from countries tracking global vaccine roll-out
Emphasising that the global pandemic is ‘not over’, the ACT-Accelerator’s Council Tracking and Accelerating Progress Working Group – co-chaired by Indonesia and the US...
Europe – Regulatory information – adjusted fees for pharmacovigilance applications from 3 October 2022
Pharmacovigilance fees payable to the European Medicines Agency by applicants and marketing authorisation holders increase by 5.6% as of 3 October 2022, to reflect the inflation rate...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2022
New measures for terlipressin-containing medicines in the treatment of hepatorenal syndrome
EMA’s safety committee (PRAC) recommended new measures to reduce the risk of respiratory failure...
Europe – EMA pilot offers enhanced support to academic and non-profit developers of advanced...
EMA is launching a pilot to support the translation of basic research developments into medicines that could make a difference in patients’ lives in...
USA – Industry groups: Expand FDA’s RTOR guidance to cell and gene therapies
Stakeholders commenting on the US Food and Drug Administration (FDA) draft guidance with recommendations for applicants submitting New Drug Applications (NDA) and Biologic License...
USA – FDA seek to harmonize human subject protections with revised Common Rule
The US Food and Drug Administration (FDA) on Tuesday issued two proposed rules aimed at harmonizing certain sections of the agency’s regulations on human...
USA – New FDA guidance offers ethical roadmap for including children in clinical trials
The US Food and Drug Administration (FDA) has issued draft guidance outlining a series of ethical considerations for conducting clinical trials that involve children.
The guidance,...
