USA – Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers
This guidance provides answers to commonly asked questions from applicants and other interested parties (collectively referred to as applicants throughout this guidance) regarding postapproval...
UK – J&J’s Tecvayli recommended by NICE to treat relapsed and refractory multiple myeloma
The final draft guidance specifically applies to patients who have received at least three prior treatments, have progressed on their last treatment, and would...
France – Définition des conditions méthodologiques requises pour la prise d’un pari lors d’une...
Le bilan des procédures accélérées aux Etats-Unis, qui s’appuie sur plus de 30 ans d’expérience de la FDA, a montré que les études confirmatoires...
Europe – Development and manufacture of oligonucleotides – Scientific guideline
This guideline addresses specific aspects regarding the manufacturing process, characterisation, specifications and analytical control for synthetic oligonucleotides which are not covered in the Guideline...
UK – NICE recommends Accord’s oral hormone therapy Orgovyx for advanced prostate cancer
The androgen deprivation therapy (ADT), which has been specifically recommended for those with hormone-sensitive cases of the disease, is now the first oral treatment...
Europe – EMA confirms its recommendation to update the antigenic composition of authorised COVID-19...
In April 2024, the European Medicines Agency (EMA) issued a recommendation to change the antigenic composition of authorised COVID-19 vaccines for use during the...
USA – FDA unveils rare disease innovation hub, plans public meeting this fall
The US Food and Drug Administration (US) announced the creation of a Rare Disease Innovation Hub to speed development of new treatments, integrate regulation...
USA – FDA guidance addresses developing treatments for pediatric IBD
The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance to spur the development of new treatments for pediatric ulcerative colitis...
USA – FDA makes exception for antibody drug conjugates in mass balance studies final...
The US Food and Drug Administration (FDA) has finalized a guidance that lays out clinical pharmacology information that sponsors of investigational drugs conducting human...
USA – FDA issues final guidance user fees for combination products
The US Food and Drug Administration (FDA) on Tuesday finalized guidance for sponsors explaining how it assesses user fees for combination products and the...
