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...
Institutional Review Board (IRB) submissions: Necessary for usability tests?

USA – FDA addresses alternative inspection tools, expectations for nitrosamine assessments in updated CPGs

The US Food and Drug Administration’s (FDA) has updated two compliance program guides (CPGs) covering pre-approval inspections (PAIs) and routine good manufacturing practice (GMP)...
Levothyrox : l’ANSM publie les dernières données issues de l’enquête de pharmacovigilance

Europe – Codéine et ibuprofène (Antarene codeine) : cas d’abus/dépendance et mise en garde...

Le comité de pharmacovigilance (PRAC) de l’Agence européenne des médicaments (EMA) recommande de nouvelles mesures pour réduire les risques d’insuffisance respiratoire et de sepsis...

USA – FDA releases discussion paper on distributed and point-of-care manufacturing

The US Food and Drug Administration (FDA) has released a discussion paper on emerging and advanced manufacturing technologies concerning the distributed manufacturing (DM) and...

Europe – New vaccine to protect people in the EU and worldwide against dengue

EMA’s human medicines committee (CHMP) has adopted a positive opinion for Dengue Tetravalent Vaccine (live, attenuated) Takeda, used to prevent disease caused by dengue...

Europe – First therapy to treat transplant patients with post-transplant lymphoproliferative disease

The European Medicines Agency (EMA) has recommended a marketing authorisation in the European Union (EU) for Ebvallo (tabelecleucel) for the treatment of adult and paediatric...

Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...

10 new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its October 2022 meeting. The CHMP recommended granting a marketing authorisation for Dengue Tetravalent...

USA – FDA expands bivalent COVID boosters to kids as young as 5

The US Food and Drug Administration (FDA) has updated the emergency use authorizations (EUA) for the bivalent Pfizer-BioNTech and Moderna COVID-19 boosters to expand...

International – ICH advances guidelines on selective reporting of safety data, viral safety

The International Council for Harmonisation (ICH) recently announced the adoption of its E19 guideline, which outlines a risk-based approach for collecting safety data for...

Europe – Data Quality Framework for EU medicines regulation

As acknowledged in the recommendations of the HMA-EMA Joint Big Data Task Force (BDTF) and the workplan of the HMA-EMA Joint Big Data Steering...