USA – FDA issues draft guidance on dosage and administration labeling
The US Food and Drug Administration (FDA) has issued draft guidance aimed at improving the consistency of information in the dosage and administration section...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 – 12...
Alignment of dose recommendations for Janus kinase (JAK) inhibitors in patients with certain risk factors
EMA’s safety committee, PRAC has further reviewed measures to minimise the risk of serious...
International – ICH guideline M10 on bioanalytical method validation and study sample analysis –...
In response to questions posted to ICH M10 comment period, a number of Questions and Answers have been devised to provide clarity around some...
USA – FDA revises guidance on delaying, denying, limiting or refusing an inspection
On Dec. 15, 2022, the FDA released for public comment Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1....
USA – CDER chief: Improving clinical trials is on to-do list
Encouraging researchers and sponsors to simplify clinical trials and employ a fit-for-purpose protocol is one way that the US Food and Drug Administration (FDA)...
France – Gustave-Roussy choisit Synapse Medicine pour sécuriser ses prescriptions complexes
VILLEJUIF (Val-de-Marne), BORDEAUX (TICsanté) - Le centre de lutte contre le cancer Gustave-Roussy a noué un partenariat avec l'entreprise bordelaise Synapse Medicine, qui développe...
International – ICH guideline Q13 on continuous manufacturing of drug substances and drug products
This guideline applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. It is applicable to CM for new...
USA – Drugmakers, advocacy groups ask FDA to clarify expanded access draft guidance
Pharmaceutical companies and research advocacy groups are asking the US Food and Drug Administration (FDA) to clarify some of the provisions of its recently...
USA – Provider groups, researchers raise concerns about extrapolating adult data in children
Clinicians and researchers are voicing concerns that the US Food and Drug Administration (FDA) has overemphasized the role for extrapolating adult data in pediatric...
USA – Stakeholders seek flexibility, greater harmonization in FDA human subject protection rules
Commenters from the pharmaceutical and medical device industries, academia and medical groups urged the US Food and Drug Administration (FDA) to help ease the...
