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The US Food and Drug Administration (FDA) released new draft guidance on developing antimicrobial drugs specifically intended to treat diabetic foot infection, a focused...
Europe – Clinical investigation of recombinant and human plasma-derived factor IX products – Scientific...
This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or human plasma-derived factor IX products is made for use...
USA – FDA issues guidance documents on labeling drug identity, constituents
The US Food and Drug Administration (FDA) has issued two draft guidance documents aimed at improving the consistency of labeling for both over-the-counter (OTC)...
France – « Contre la résistance aux antibiotiques, la recherche et la production publiques...
La Journée mondiale de prévention de l’antibiorésistance qui s’est tenue le 18 novembre a alerté sur cette menace sanitaire croissante considérée par les instances internationales...
USA – Accès précoce et compassionnel: mise en oeuvre de l’authentification unique pour le...
PARIS (TICpharma) - Les modalités d'authentification unique des professionnels aux plateformes de recueil des données relatives aux accès précoce et compassionnel, via un service...
International – ICH M12: Pharma industry wants clarity on rifampin dosing, more information on...
The pharmaceutical industry would like the International Council for Harmonization (ICH) to clarify dosing information for rifampin and requests additional information on the use...
UK – Bristol Myers Squibb’s acute myeloid leukaemia oral maintenance therapy recommended by NICE
The recommendation is specifically for use in patients who have achieved complete remission or complete remission with incomplete blood count recovery following induction therapy...
Europe – ICH Guideline M12 on drug interaction studies
This guideline provides recommendation to promote a consistent approach in designing,
conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies...
