USA – MedCon: TAP pilot off the ground four devices enrolled
The US Food and Drug Administration (FDA) has enrolled the first four devices in its Total Product Life Cycle Advisory Program (TAP) pilot, while...
USA – FDA considers new efficacy endpoint for diabetes drugs
The US Food and Drug Administration (FDA) on Friday released an updated draft guidance to help sponsors demonstrate efficacy for new antidiabetic drugs and...
Europe – DARWIN EU® has completed its first studies and is calling for new...
DARWIN EU®, the Data Analysis and Real-World Interrogation Network, has accomplished its first year of establishment. Following the set-up of the DARWIN EU® Coordination...
Europe – First therapy to treat rare genetic nervous system disorder AADC deficiency
EMA has recommended granting a marketing authorisation in the European Union (EU) for Upstaza (eladocagene exuparvovec), a therapy for the treatment of adult and paediatric patients...
France – Covid-19 : l’Agence européenne des médicaments autorise la mise sur le marché...
C’est le sixième vaccin contre le Covid-19 recommandé chez les adultes au sein des vingt-sept pays de l’Union européenne. L’Agence européenne des médicaments (AEM)...
Europe – EMA offers insights on when biologics qualify as new active substances
The European Medicines Agency (EMA) is looking for feedback on a draft reflection paper that lays out its criteria for determining whether biological substances...
USA – FDA releases draft guidance to spur development of CDI drugs
The US Food and Drug Administration (FDA) has issued new draft guidance with advice for sponsors on developing drugs for treating Clostridioides difficile infection (CDI).
The draft...
International – ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from...
This guideline concerns the testing and evaluation of the viral safety of biotechnology products, and it outlines what data should be submitted in marketing...
Europe – New general chapter on implementation of pharmacopoeial procedures published in the 11th...
A new general chapter, Implementation of pharmacopoeial procedures (5.26), has just been published in the 11th Edition of the European Pharmacopoeia (Ph. Eur.). The text was adopted...
USA – FDA offers new guidance on therapeutic equivalence evaluations
In draft guidance issued on Wednesday, the US Food and Drug Administration (FDA) explains its approach to therapeutic equivalence (TE) evaluations and the assignment...
