USA – FDA issues draft guidance on mpox drug development
In a much-anticipated draft guidance issued on Thursday, the US Food and Drug Administration (FDA) said that unlike smallpox therapeutics, treatments for mpox cannot...
International – Efficacité et tolérance des vaccins contre la COVID‐19
Nous avons inclus et analysé 41 ECR évaluant 12 vaccins différents, y compris les schémas vaccinaux homologues et hétérologues et l'effet des doses de...
USA – FDA encourages RCTs in accelerated approval guidance for oncology
The US Food and Drug Administration (FDA) issued draft guidance on the design of oncology trials for accelerated approval, calling randomized controlled trials (RCTs)...
Europe – EMA reviewing data on sabizabulin for COVID-19
EMA’s Emergency Task Force (ETF) has started a review of data on the use of sabizabulin for treating COVID-19.
The review will look at all available...
Europe – Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for...
The assessment report of the CHMP’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products provides general guidance...
Europe – Procedural advice on publication of information on withdrawals of applications for marketing...
This paper describes the publication of information on the withdrawals of marketing authorisation applications for human medicinal products and withdrawals of applications for variations/extensions...
USA – FDA takes first step to allow low-dose OTC naloxone on market
Low-dose naloxone drug products, including certain nasal sprays and autoinjectors, could one day be sold without a prescription, according to an initial assessment by...
International – WHO issues guidance on nitrosamine controls in drug manufacturing
The World Health Organization (WHO) released draft guidance for comment this month on good manufacturing practices (GMP) for the prevention and control of contamination...
USA – Generic manufacturers call for changes to list of major deficiencies
Generic drug manufacturers are urging the US Food and Drug Administration (FDA) to revise its guidance on amendments to Abbreviated New Drug Applications (ANDA)...
France – L’ANSM classe plusieurs vaccins sur la liste I des substances vénéneuses
L’ensemble des vaccins, à l’exception des vaccins grippaux, est désormais classé sur la liste I des substances vénéneuses, à la suite d’une décision de...
