USA – FDA relaxes EUA advertising limitation for some COVID drugs
The US Food and Drug Administration (FDA) has relaxed a limitation on advertising and promotion for certain COVID-19 drugs with emergency use authorizations (EUAs)....
USA – FDA issues final guidance on nicotine replacement therapy
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday issued a final guidance to assist sponsors interested...
USA – FDA publishes additional guidances on delay of enforcing DSCSA electronic tracking requirements
The US Food and Drug Administration (FDA) published two additional guidances with immediate effect that provide more details for trading partners on the one-year...
USA – FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy
Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years...
France – HAS : Covid-19 – un avis global sur les vaccins bivalents mi-septembre
L’Agence européenne des médicaments (EMA) vient de modifier les autorisations de mise sur le marché (AMM) accordées aux vaccins à ARN messager développés par...
France – L’agence du médicament sonne l’alarme au sujet de réactions allergiques associées à...
L’Agence nationale de sécurité du médicament et des produits de santé (ANSM) a observé une « augmentation constante du nombre de déclarations de réactions allergiques graves...
UK – Pfizer’s Litfulo recommended by NICE as first treatment for severe alopecia areata
NICE’s decision, which could benefit up to 14,000 patients, makes Litfulo the first treatment for severe alopecia areata to be recommended by the agency...
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Public comments submitted to the US Food and Drug Administration’s (FDA) draft guidance on how and when to inform the agency of certain drug...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 – UK to introduce new regulatory framework for point of care manufacturing
The framework will ensure that there are no regulatory barriers to innovative manufacturing and that these products have the same assurances of safety, quality...
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...
