Europe – European Pharmacopoeia seeking user feedback on use of recombinant factor C for...
General chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C was published in Supplement 10.3 of the European Pharmacopoeia (Ph. Eur.) and came into force on 1 July 2021....
Europe – Clinical Trials Information System (CTIS) – Sponsor Handbook
The aim of the EMA CTIS Sponsor Handbook (‘Handbook’) is to provide clinical trial (CT) sponsors representing pharmaceutical industry, SME (small and medium-sized enterprises),...
UK – NICE issues final appraisal recommending LEO Pharma’s Adtralza for moderate-to-severe atopic dermatitis
The recommendation is specifically for adult patients with the condition who are eligible for systemic treatment, only if the disease has not responded to...
USA – Cavazzoni: Pandemic-era tools, learnings are here to stay
The US Food and Drug Administration’s (FDA) top drug official said the pandemic has prompted the agency to consider new ways of working going...
France – L’ANSM classe l’hexahydrocannabinol (HHC) et deux de ses dérivés sur la liste...
Cette décision fait suite aux travaux réalisés à notre demande par les centres d'évaluation et d'information sur la pharmacodépendance-addictovigilance (CEIP-A). Ces travaux ont rapporté que...
International – ICH M10 on bioanalytical method validation
This guideline is intended to provide recommendations for the validation of bioanalytical methods for chemical and biological drug quantification and their application in the...
USA – FDA guidance details new advanced manufacturing technology designation program
The US Food and Drug Administration (FDA) this week issued draft guidance detailing its new advanced manufacturing technologies (AMT) designation program, offering insights on...
USA – Experts discuss red flags that can trigger legal action against drug and...
Legal observers discussed some of the red flags that can trigger legal actions against healthcare product manufacturers, as well as some of the lessons...
France – Médicaments à base de miansérine : rappel du bon usage et des...
Ces dernières années, des signalements d’usage non conforme de miansérine, dans la prise en charge de troubles du sommeil, chez des patients sans...
USA – FDA issues draft guidance on developing drugs for acromegaly
The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors develop acromegaly treatments for patients who have either not...
