USA – Sentinel System expands capacity, data linkages, report indicates
The US Food and Drug Administration’s Sentinel System, which monitors the safety of approved medical products, has expanded its capacity to support regulatory decisions...
Europe – EMA Management Board: highlights of October 2022 meeting
COVID-19
At its 6 October 2022 meeting in Amsterdam, the European Medicines Agency (EMA) Management Board heard an update on the recent activities related to...
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 active ulcerative colitis treatment bags NICE recommendation
The recommendation is specifically for patients who are intolerant of, or whose condition has had an inadequate response, or loss of response to previous...
USA – FDA updates guidances to clarify new generic drug meeting requirements in GDUFA...
The US Food and Drug Administration (FDA) has updated four guidances to address new commitments made in the latest Generic Drug User Fee Amendments...
France – Certification des logiciels d’aide à la dispensation (LAD) de pharmacie à usage...
La procédure de certification
La procédure de certification des LAD s'applique avec le référentiel de certification des logiciels d’aide à la dispensation de pharmacie à usage intérieur...
USA – FDA issues guidances on facility readiness and early DMF assessments under GDUFA...
The US Food and Drug Administration’s (FDA) on 3 October released two draft guidances that implement new enhancements under the new Generic Drug User...
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...
International – ICH Q14: Pharma groups want clarity on benefits of enhanced approach
Pharmaceutical industry groups questioned whether following the enhanced approach in International Council for Harmonization (ICH) Q14 guidance will confer regulatory relief for manufacturers that...
USA – FDA warns that emerging Omicron subvariant could make Evusheld obsolete
AstraZeneca’s Covid-19 pre-exposure prophylactic Evusheld has managed to remain relevant for immunocompromised and other patients when many of its therapeutic peers haven’t with each...
