An FDA CBER Workshop for Patient Advocates on 24 May 2022. FDA staff and panellists explored how natural history studies contribute to improved understanding of diseases and drug development, including regenerative medicine treatments such as...
This draft guidance addresses certain requirements that apply to blood establishments that collect blood and blood components, including Source Plasma. In relation to Title 21 of the Code of Federal Regulations 630.30 (21 CFR 630.30) regarding donation...
The FDA’s Center for Drug Evaluation and Research (CDER) announced on the 10th of May 2022 the launch of the new Accelerating Rare disease Cures (ARC) Program harnesses CDER’s collective expertise and activities to provide...
Kymriah is now FDA approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings. See all of Catapult’s Regulatory Round-up for May 2022 here. Published on the...
The UK is set to play a greater international role in making sure medicines and medical devices are regulated safely and efficiently worldwide, the Medicines and Healthcare products Regulatory Agency (MHRA) announced today after being...
Read more on https://www.ris.world/europe-regulation-on-emas-extended-mandate-becomes-applicable/
Read more info under https://www.mappatientaccess.com/insights/?post=future-ema-and-hta-relations
Aux Etats-Unis, la Food and Drug Administration (FDA) a imposé la suspension d’un essai clinique de phase Ib qui visait à évaluer une thérapie génique pour la dystrophie musculaire de Duchenne (DMD) développée par Pfizer,...
The ISSCR submitted comments to the UK’s MHRA on the Consultation on Point of Care Manufacturing that state, among other key points: We are particularly concerned that purveyors of autologous adipose-derived cell therapies might seek to exploit...
On 13 January 2022, “the European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have launched an initiative to transform how clinical trials are initiated, designed and run, referred to as Accelerating Clinical Trials...
