International – ICH M11 guideline, clinical study protocol template and technical specifications
The purpose of this new harmonised guideline is to introduce the clinical protocol template and the technical specification to ensure that protocols are prepared in a...
USA – FDA updates guidance on expanded access for investigational drugs under IND
The US Food and Drug Administration (FDA) has updated its guidance for industry on expanded access to investigational drugs under an investigational new drug...
USA – FDA announces CMC review pilot for drugs with expedited development
The US Food and Drug Administration (FDA) announced on 31 October a limited chemistry, manufacturing and controls (CMC) development and readiness pilot (CDRP) program...
Europe – EMA grants AZ’s Vaxzevria COVID-19 vaccine full marketing authorisation
Previously, Vaxzevria was given a conditional Marketing Authorisation (cMA) due to the critical nature of the COVID-19 pandemic, and as further significant evidence of...
USA – FDA draft guidance aims to ensure accurate measurements of pediatric growth
Joint draft guidance from two centers at the US Food and Drug Administration (FDA) outlines ways sponsors can measure pediatric growth consistently in clinical...
USA – FDA releases draft guidance to spur development of CDI drugs
The US Food and Drug Administration (FDA) has issued new draft guidance with advice for sponsors on developing drugs for treating Clostridioides difficile infection (CDI).
The draft...
Europe – EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
EMA’s safety committee (PRAC) has confirmed its recommendation to withdraw the marketing authorisations for amfepramone obesity medicines. This follows a re-examination of its previous recommendation of June 2022, which was...
Europe – EMA recommends measures to minimise risk of serious side effects with Janus...
EMA’s safety committee (PRAC) has recommended measures to minimise the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat...
International – ICH : Clinical Electronic Structured Harmonised Protocol (CESHARP) M11
The clinical protocol describes the processes and procedures directing the conduct and analysis of a clinical trial of medicinal product(s) in humans. To date,...
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...
