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 – FDA warns industry about potential data integrity issues with third-party labs
The US Food and Drug Administration (FDA) is warning medtech sponsors and manufacturers to double-check the work of third-party testing laboratories before their data...
Europe – EMA proposes new guideline on non-inferiority trials
The European Medicines Agency (EMA) is proposing a new guideline on sponsors’ use of non-inferiority designs to assess the safety and effectiveness of new...
International – ICH consults on revised post-approval safety guideline that accounts for digital platforms
The International Council for Harmonisation (ICH) recently announced that its new draft E2D(R1) guideline on post-approval data and individual case safety reports (ICSRs) has...
Switzerland – Swiss Medtech soutient les négociations concernant un paquet d’accords bilatéraux lll
Pour l'industrie suisse des technologies médicales, la sécurité juridique est primordiale dans les relations avec l’UE. Swiss Medtech soutient donc le Conseil fédéral dans...
USA – FDA finalizes guidance on charging for investigational drugs
The US Food and Drug Administration (FDA) on 14 February finalized guidance specifying the circumstances when sponsors can charge for an investigational drug in...
USA – FDA issues new draft guidance on data monitoring committees
The US Food and Drug Administration (FDA) on Monday issued a new draft guidance advising certain product sponsors to establish data monitoring committees (DMCs)...
Germany – Germany will revise laws for clinical trials with pharmaceuticals, medical devices and...
Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented...
Europe – Evaluation of medicinal products indicated for treatment of bacterial infections
This guideline merges, revises and adds to the guidance previously included in the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev...
UK – NICE recommends STADA and Calliditas’ Kinpeygo to treat rare kidney disease IgAN
Affecting approximately 14,000 people in England, IgAN occurs when IgA accumulates in the kidneys, causing inflammation and scarring, which can lead to kidney failure.
Patients...
