USA – How to learn about biologics CMC: advice on technical issues, regulatory strategy,...
Chemistry, manufacturing and controls (CMC) are an integral step in creating an effective biological product — and a crucial element of an effective biologics...
International – ICH targets cell and gene therapies, real-world data as topics ripe for...
Officials from Health Canada and the pharmaceutical industry addressed plans to develop harmonized guidelines on cell and gene therapies and on the design of...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
10 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting.
The committee adopted positive opinions...
USA – Industry urges FDA to do more to help companies prepare for DSCSA
The pharmaceutical industry urged the US Food and Drug Administration (FDA) to take a more “assertive and forward-leaning” approach in assisting pharmaceutical manufacturers prepare...
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...
