UK – UK announces COVID boosters for a “bumpy winter” ahead

Health secretary Sajid Javid said the decision to launch a booster programme was made on the advice of the country’s expert panel, the Joint...

USA – Medicare could negotiate drug prices under Biden plan

The Biden administration on Thursday unveiled a detailed blueprint for lowering prescription drug prices that includes aggressive proposals backed by congressional Democrats. The blueprint includes...

Europe – EMA : Guidance documents

This page lists documents related to data submission for authorised medicines, including the legal notice, detailed guidance documents and controlled vocabularies for the Extended EudraVigilance...

International – Convergence: Regulatory considerations in advancing gene and cellular therapies

When developing a regulatory submission for a gene or cellular therapy, it’s essential to keep the basics in mind, such as how to demonstrate...
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France – RGPD : Q & R

Question 1 : Qu’est-ce qu’une base légale ? Pour pouvoir être mis en oeuvre, tout traitement de données doit se fonder sur l’une des « bases légales » prévues...

International – Challenges of non-clinical safety testing for biologics: A Report of the 9th...

New challenges and other topics in non-clinical safety testing of biotherapeutics were presented and discussed at the nineth European BioSafe Annual General Membership meeting...

France – Publication des référentiels de certification des LAP hospitaliers et en ambulatoire (JO)

PARIS (TICsanté) - Deux décisions de la Haute autorité de santé (HAS) relatives aux référentiels fonctionnels de logiciels d'aide à la prescription (LAP) de...

USA – FDA launches excipient pilot program

The US Food and Drug Administration (FDA) has launched a new pilot program to review novel excipients for use in meeting unmet needs in formulating new...

USA – FDA reaches milestone in generics approvals

The Food and Drug Administration is marking progress in its efforts to bring more generics to market for products that have little or no...

International – Vaccin contre le Covid-19 : bientôt un spray nasal pour stopper le...

Démodé la piqûre dans le bras, vous recevrez peut-être demain un vaccin dans le nez. La technologie déjà utilisée aux États-Unis contre la grippe...

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