The FDA and PQRI have announced that they will host an FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing on November 14 – 16, 2022, as a virtual event. This virtual workshop is open to anyone interested in DM/POC, specifically to learn from experts and contribute ideas. Registration can be found here. Visit the Workshop website for more information. See all of Catapult's Regulatory Round-up for August 2022 here. Published on the 1st o..
With the launch of the UK Academy of Pharmaceutical Sciences Advanced Therapy Medicinal Products Foc...
With the launch of the UK Academy of Pharmaceutical Sciences Advanced Therapy Medicinal Products Foc...
Federal agencies need to establish a consistent framework to regulate laboratory developed tests (LD...
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...
Title Consultation Period Category Considerations for Rescinding Breakthrough Therapy Designat...
Goal: This annual medical device conference, now in its 13th year, provides attendees with 2 days of...
Human Gene Therapy Products Incorporating Human Genome Editing End Date: 14 Jul 2022 Draft Guidance ...
Point-of-care (POC) manufacture can be defined as the production of therapies in clinical settings o...
The US Food and Drug Administration (FDA) held a workshop on red blood cell (RBC) product regulatory...
On 2 June, the European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medici...
With In Silico offering an understanding of complexity on a scale never before known in human histo...
This presentation was shared with colleagues at the 2018 VPH Institute Conference that took place in...
These slides were presented as part of the FDA Grand Rounds on August 9, 2018.FDA recognizes the pub...
On May 4, 2020, the US Food and Drug Administration (FDA) hosted an online public workshop titled "F...
With the launch of the UK Academy of Pharmaceutical Sciences Advanced Therapy Medicinal Products Foc...
With the launch of the UK Academy of Pharmaceutical Sciences Advanced Therapy Medicinal Products Foc...
Federal agencies need to establish a consistent framework to regulate laboratory developed tests (LD...
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...
Title Consultation Period Category Considerations for Rescinding Breakthrough Therapy Designat...
Goal: This annual medical device conference, now in its 13th year, provides attendees with 2 days of...
Human Gene Therapy Products Incorporating Human Genome Editing End Date: 14 Jul 2022 Draft Guidance ...
Point-of-care (POC) manufacture can be defined as the production of therapies in clinical settings o...
The US Food and Drug Administration (FDA) held a workshop on red blood cell (RBC) product regulatory...
On 2 June, the European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medici...
With In Silico offering an understanding of complexity on a scale never before known in human histo...
This presentation was shared with colleagues at the 2018 VPH Institute Conference that took place in...
These slides were presented as part of the FDA Grand Rounds on August 9, 2018.FDA recognizes the pub...
On May 4, 2020, the US Food and Drug Administration (FDA) hosted an online public workshop titled "F...
With the launch of the UK Academy of Pharmaceutical Sciences Advanced Therapy Medicinal Products Foc...
With the launch of the UK Academy of Pharmaceutical Sciences Advanced Therapy Medicinal Products Foc...
Federal agencies need to establish a consistent framework to regulate laboratory developed tests (LD...