USA – FDA Approves New Class of Medicines to Treat Pediatric Type 2 Diabetes
Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve...
International – Genetically altered vaccines developed to help eradicate polio
Polio is a highly infectious viral disease that largely affects children aged under five years. The virus is transmitted by person-to-person and multiplies in...
USA – FDA details policy on facility reclassification requests under GDUFA III
The US Food and Drug Administration (FDA) recently issued a manual of policies and procedures (MAPP) on the procedures it will follow in following...
France – Relocalisations de médicaments essentiels – Dossier de presse le 13/06/2023
France 2030 traduit une double ambition : transformer durablement des secteurs clefs de notre économie (énergie, automobile, santé, aéronautique, etc.) par l’innovation
technologique et industrielle,...
Europe – European Health Union: EU steps up the fight against antimicrobial resistance
The Commission welcomes today's adoption by the Council of the European Union of the Commission's proposal to strengthen EU action against antimicrobial resistance (AMR).
Announced together with...
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Public comments submitted to the US Food and Drug Administration’s (FDA) draft guidance on how and when to inform the agency of certain drug...
