Add to ORKGTitle Consultation Period Category Considerations for Rescinding Breakthrough Therapy Designation End Date: 23 Aug 2022 Draft Guidance See all of Catapult's Regulatory Round-up for August 2022 here. Published on the 1st of september 2022
Life sciences companies seeking protection for their biological products gain clarity on the submiss...
The phrase "bench-to-bedside" is commonly used to describe the translation of basic discoveries such...
1.BackgroundCommunicating information on the regulatory framework applicable to gene and cell therap...
Human Gene Therapy Products Incorporating Human Genome Editing End Date: 14 Jul 2022 Draft Guidance ...
The aim of this consultation is to seek the views of stakeholders on proposals to amend statutory fe...
The FDA hosted a workshop back in May – the Annual Patient Engagement & Regenerative Medicine Meetin...
The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapi...
The FDA has approved bluebird bio’s gene therapy betibeglogene autotemcel (beti-cel), now marketed a...
On the 30th of August, the European Commission (EC), HMA and EMA published the 2022-2026 Workplan of...
The FDA and PQRI have announced that they will host an FDA/PQRI Workshop on the Regulatory Framework...
On 2 June, the European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medici...
The Advanced Therapy Medicinal Products (ATMP) Flow Cytometry and Vector Copy Number best practice g...
The FDA approved lisocabtagene maraleucel for treatment of adults with relapsed or refractory large ...
The FDA has approved an update to the voretigene neparvovec-rzyl (Luxturna) post-marketing experienc...
The EMA launched the enhanced EudraVigilance system in November 2017 to support the reporting and an...
Life sciences companies seeking protection for their biological products gain clarity on the submiss...
The phrase "bench-to-bedside" is commonly used to describe the translation of basic discoveries such...
1.BackgroundCommunicating information on the regulatory framework applicable to gene and cell therap...
Human Gene Therapy Products Incorporating Human Genome Editing End Date: 14 Jul 2022 Draft Guidance ...
The aim of this consultation is to seek the views of stakeholders on proposals to amend statutory fe...
The FDA hosted a workshop back in May – the Annual Patient Engagement & Regenerative Medicine Meetin...
The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapi...
The FDA has approved bluebird bio’s gene therapy betibeglogene autotemcel (beti-cel), now marketed a...
On the 30th of August, the European Commission (EC), HMA and EMA published the 2022-2026 Workplan of...
The FDA and PQRI have announced that they will host an FDA/PQRI Workshop on the Regulatory Framework...
On 2 June, the European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medici...
The Advanced Therapy Medicinal Products (ATMP) Flow Cytometry and Vector Copy Number best practice g...
The FDA approved lisocabtagene maraleucel for treatment of adults with relapsed or refractory large ...
The FDA has approved an update to the voretigene neparvovec-rzyl (Luxturna) post-marketing experienc...
The EMA launched the enhanced EudraVigilance system in November 2017 to support the reporting and an...
Life sciences companies seeking protection for their biological products gain clarity on the submiss...
The phrase "bench-to-bedside" is commonly used to describe the translation of basic discoveries such...
1.BackgroundCommunicating information on the regulatory framework applicable to gene and cell therap...