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...
USA – FDA finalizes guidances on RWD in regulatory submissions, assessing registries
The US Food and Drug Administration (FDA) on Thursday finalized two guidances that detail how sponsors can leverage and submit real-world data (RWD) in...
USA – Accelerated approval trials: Commenters seek details on single-arm considerations
The US Food and Drug Administration (FDA) aimed to address some of the criticisms of its accelerated approval program with new draft guidance that...
Europe – EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic...
The European Medicines Agency has been notified by relevant national competent authorities that pre-filled pens falsely labelled as the diabetes medicine Ozempic (semaglutide, 1 mg, solution...
USA – Industry experts tout potential for master protocols in pediatric clinical trials
Using master protocols in pediatric clinical trials could speed the development of drugs for pediatric indications that already have development programs for adults, according...
International – ICH M10 on bioanalytical method validation
This guideline is intended to provide recommendations for the validation of bioanalytical methods for chemical and biological drug quantification and their application in the...
Europe – Procedural advice on paediatric applications
The Paediatric Regulation came into force in the European Union (EU) on 26 January 2007. Its objective is to improve the health of children...
USA – FDA finalizes guidance on REMS format and content
The US Food and Drug Administration (FDA) on Wednesday finalized guidance outlining its expectations for the format and content of a risk evaluation and...
USA – Data Integrity for In Vivo Bioavailability and Bioequivalence Studies: Guidance for Industry
The purpose of this guidance is to provide recommendations to applicants and testing site
management on achieving and maintaining data integrity for the clinical and...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Eight new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2024 meeting.
The CHMP recommended granting a marketing authorisation for Altuvoct* (efanesoctocog alfa), for...
