USA – FDA offers first guidance on stimulant use disorder drug development
The US Food and Drug Administration (FDA) has published a draft guidance that for the first time offers recommendations for drug development and clinical...
Europe – EMA Management Board: highlights of October 2023 meeting
EMA’s Management Board met on 5 October in Amsterdam.
Clinical trials in the EU
The Board adopted revised transparency rules for the publication of information on clinical...
USA – FDA updates policies for reviewing ANDAs
The US Food and Drug Administration (FDA) has revised its manual of policies and procedures (MAPP) for conducting a filing review of an abbreviated...
USA – FDA finalizes guidance on dose banding for injectables
The US Food and Drug Administration (FDA) has finalized its guidance on dose banding to assist sponsors in labeling ready-to-use containers for injectable drug...
USA – FDA guidance explores trial design, supporting data for GVHD treatments
In preparation for a potential “paradigm shift” in the management of graft-versus-host disease (GVHD), the US Food and Drug Administration (FDA) is seeking comment...
USA – FDA adds breakpoint updates to antimicrobial susceptibility test system device labeling guidance
The US Food and Drug Administration (FDA) has updated its final guidance on antimicrobial susceptibility test (AST) system device labeling based on breakpoint updates...
Europe – Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for...
The assessment report of the CHMP’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products provides general guidance...
France – Chimiothérapies par fluoropyrimidines (5-FU) : l’Institut et la HAS actualisent leurs recommandations...
Chaque année en France, près de 80 000 personnes atteintes d’un cancer - principalement digestif, du sein ou ORL - sont traitées par une...
Europe – EFPIA: EU pharma manufacturing would ‘grind to a halt’ under proposed PFAS...
The European Union’s proposed restriction on the use of per- and polyfluoroalkyl substances (PFAS), also known as “forever chemicals,” would have grave implications on...
USA – CBER revises internal procedures for processing clinical holds, NDAs and BLAs
The US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has published two internal policy guides for staff outlining procedures for...
