USA – Guidance details updated FDA GDUFA fees, structure and appeals process
The US Food and Drug Administration (FDA) published a final guidance last week that updates the agency’s user fee structure and other aspects of...
Europe – Guidance on paediatric submissions
The following guidance outlines the main steps to take to prepare for submission, and a list of documents required for the main1 types of...
USA – FDA officials say high priority will be given to applications with endpoints...
Under the US Food and Drug Administration (FDA) rare disease endpoint advancement pilot program (RDEA), preference will be given to applications with well-developed efficacy...
Europe – EMA Management Board: highlights of June 2023 meeting
The European Commission informed the Board about its legal proposals to revise the pharmaceutical legislation, published on 26 April, which aim to make the...
USA – Manufacturers seek clarity on FDA’s drug shortage notification guidance
Public comments submitted to the US Food and Drug Administration’s (FDA) draft guidance on how and when to inform the agency of certain drug...
UK – NICE nod for AstraZeneca’s Lynparza
Therapy treats patients with specific types of ovarian, fallopian tube or primary peritoneal cancer
The National Institute for Health and Care Excellence (NICE) has recommended...
France – L’ANSM classe l’hexahydrocannabinol (HHC) et deux de ses dérivés sur la liste...
Cette décision fait suite aux travaux réalisés à notre demande par les centres d'évaluation et d'information sur la pharmacodépendance-addictovigilance (CEIP-A). Ces travaux ont rapporté que...
USA – FDA seeks feedback on ICH E6(R3) GCP guideline
The US Food and Drug Administration (FDA) has started its public consultation for the International Council for Harmonisation (ICH) guideline on good clinical practice...
USA – FDA officials: ‘Significant work’ still needed for rare disease drug development
While much progress has been made in approving treatments for rare diseases, more work is needed in this area, asserted Kerry Jo Lee, MD,...
Europe – EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2...
The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) have issued a joint statement on adapted COVID-19 vaccines and considerations...
