Europe – New features further strengthen Priority Medicines scheme (PRIME)
EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to strengthen its support for the development of medicines in areas of...
Europe – EMA annual report 2022 published
EMA published its annual report 2022 today. The report provides an overview of the Agency’s activities to protect and promote public and animal health in the...
USA – FDA offers guidance on development of antimicrobials for diabetic foot infections
The US Food and Drug Administration (FDA) released new draft guidance on developing antimicrobial drugs specifically intended to treat diabetic foot infection, a focused...
France – Intérêt du logiciel doté d’IA « PharmaClass » pour aider le pharmacien clinicien à...
LILLE (TICsanté) - Le logiciel "PharmaClass", qui utilise l'intelligence artificielle (IA), aide le pharmacien clinicien à sécuriser la prise en charge médicamenteuse à l'hôpital,...
USA – FDA offers details on PDUFA VII STAR review pilot
The US Food and Drug Administration (FDA) has announced details on its Split Real Time Application Review (STAR) pilot, a program designed to shorten...
UK – New T-cell study demonstrates ‘powerful’ potential for tailored cancer medicine
The clinical study involved 16 patients with either colon, breast or lung cancers that had failed to respond to other treatments, and was made...
USA – FDA issues final guidance on AML drug development, two oncology draft guidances
The US Food and Drug Administration has published a final guidance and two draft guidances that detail its thinking on developing certain types of...
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The US Food and Drug Administration (FDA) has issued draft guidance outlining a series of ethical considerations for conducting clinical trials that involve children.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,...
Europe – Patient registries: EMA officials highlight opportunities in orphan drug development
Officials from the European Medicines Agency (EMA) tout the benefits of patient registries to support regulatory decision making for orphan medicinal products in a...
USA – HHS issues guidance on legally prescribed drugs for abortion
The Biden administration on Wednesday said retail pharmacies and pharmacists must provide patients with the medication they were legally prescribed even if it could...
