Latin America – Brazil, Mexico launch efforts to ease biosimilar regulation
In recent weeks, both Brazilian and Mexican regulatory authorities have made public their eagerness to spur domestic production – and faster regulation – of...
Europe – Convergence: EMA official urges transition of existing clinical trials to CTIS portal
Sponsors should plan to transition existing clinical trials into the new Clinical Trial Information System (CTIS) portal by 30 January 2025, Anabela Marcal, of...
USA – Convergence: FDA looking for ‘a new way forward’ on CBD regulation
The US Food and Drug Administration (FDA) is open to developing a new regulatory framework for cannabidiol (CBD), according to an agency official who...
USA – Convergence: Psychedelic drug development is ‘hot,’ but proceed with caution
Psychedelic drug development is receiving more attention lately as these treatments offer the potential for needed therapeutic alternatives for various mental health conditions, yet...
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The US Food and Drug Administration (FDA) has published a draft guidance that for the first time offers recommendations for drug development and clinical...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...
