USA – FDA final guidance targets neonatal pharmacology studies
The US Food and Drug Administration (FDA) issued final guidance this week to assist sponsors in developing clinical pharmacology studies for neonatal populations. The guidance is...
UK – NICE recommends Alexion’s asfotase alfa across England
Alexion Pharma’s asfotase alfa – also known as Strensiq – has been recommended by the National Institute for Health and Care Excellence (NICE) for...
Europe – EMA Procedural Advice on Recommendations on unforeseen variations according to Article 5...
Article 3 paragraph 1 of Commission Regulation (EC) No 1234/2008 (Variation Regulation) refers to Annex II where a classification of minor variations, type IA...
France – Gustave-Roussy choisit Synapse Medicine pour sécuriser ses prescriptions complexes
VILLEJUIF (Val-de-Marne), BORDEAUX (TICsanté) - Le centre de lutte contre le cancer Gustave-Roussy a noué un partenariat avec l'entreprise bordelaise Synapse Medicine, qui développe...
Europe – ECDC and EMA collaborate on vaccine safety and effectiveness monitoring studies
The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) convened on 6 and 7 December in Amsterdam the first meeting...
USA – Industry requests more information from FDA on dosage and administration labeling
While the US Food and Drug Administration’s (FDA) latest draft guidance on improving the consistency of information in the dosage and administration section of...
France – Anti-inflammatoires non stéroïdiens (AINS) et complications infectieuses graves
Les AINS, tels que l’ibuprofène, le kétoprofène, sont parmi les médicaments les plus utilisés en automédication comme antalgiques (anti-douleurs) ou antipyrétiques (anti-fièvre) chez les...
Europe – Global regulators agree on way forward to adapt COVID-19 vaccines to emerging...
International regulators have published a report today highlighting the outcomes of their discussions on COVID-19 vaccines and the need for and strategy to update their composition...
USA – FDA finalizes guidances on RWD in regulatory submissions, assessing registries
The US Food and Drug Administration (FDA) on Thursday finalized two guidances that detail how sponsors can leverage and submit real-world data (RWD) in...
USA – FDA issues guidance documents on labeling drug identity, constituents
The US Food and Drug Administration (FDA) has issued two draft guidance documents aimed at improving the consistency of labeling for both over-the-counter (OTC)...
