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Considerations for Mobile Health Technology Developers: Part 1

pharmaphorum

Part 2 of this series will be devoted to clinical decision support (CDS) software. The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. If an mHealth device is life sustaining, then the FDA is certainly going to regulate the device.

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Cell Therapy Consumables Industry: Current Scenario and Future Trends

Roots Analysis

Cell therapy is the therapeutic approach which involves the injection of healthy cells in the human body, in order to replace the diseased / non-functioning cells to regulate certain functions. Raw materials used for the production of cell therapies include culture media, growth factors, extracellular matrices and reagents.

Reagent 52
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A new era in diagnostics: The growing demand for POC testing

Pharmaceutical Technology

“In molecular devices, you have a lot of processes, and they are very complex because you are dealing with different reagents and with a variety of materials. But in the highly regulated world of medical devices, there is no margin for error, and quality standards are consistently high.

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What challenges does the advanced therapies sector face? 

Drug Discovery World

Natalia Elizalde, Chief Business Development Officer, VIVEbiotech, says that Dr Naldini’s award represents the significant benefits and demonstrated safety of the therapies developed using lentiviral vectors that are being used for more and more clinical trials and more prevalent diseases.

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Regulatory Trends in Cell and Gene Therapies

Advarra

However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines. Taken together, these initiatives offer more frequent interactions between sponsors and regulators to communicate and discuss technological advances.

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FDA INTERACT Meetings: Early Interactions for Cell and Gene Therapy Sponsors

Camargo

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Scope and design of definitive animal trials and clinical trials.

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Expert view: What’s next for cell and gene therapy?

Drug Discovery World

Investment landscape In 2023, Matthieu de Kalbermatten, CEO of CellProthera, looks forward to presenting the final safety and efficacy results of the company’s Phase II clinical trial, and for moving into Phase III. Lending to the time-to-clinic discrepancy, we also see increasing demands on manufacturing capacity for CGT reagents.”