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In the News: September Regulatory and Development Updates

Camargo

The establishment of the DHCoE is the latest of many signs that the FDA is working closely with other stakeholders to make sure that regulations keep pace with the rapid advancements in this space. Approval of the Month: FDA Approves First Closed-Loop Monitoring and Drug Delivery Device. Co-Authors: Ken Phelps.

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14th Annual Pre-Filled Syringes and Drug Devices 2022

pharmaphorum

The Future of Drug Delivery and Combination Product Device Design. The pre-filled syringes industry is growing at an exponential rate with innovations in parenteral delivery device development to aid self-administration and deliver biologics, high concentration, and large-volume drug products.

Drugs 52
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As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

FDA Law Blog

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. This was a topic at the December Food and Drug Law Institute conference on Current Developments in Digital Health Technology and Regulation.

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XPhyto Announces RT-PCR Test for Point-of-Care COVID-19 Detection

The Pharma Data

3a will continue to advance its industrial design, product usability, labelling compliance, regulatory approval, and production planning work in parallel to its validation studies. .” Final validation studies are planned to be carried out for both RNA test systems in Germany in Q4 2020. About XPhyto Therapeutics Corp.

RNA 52
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Valuable Leadership Styles for Pharmaceutical Executives

XTalks

Due to consistent changes in pharmaceutical regulation, pandemic-related disturbances and the ongoing effects of digitization, visionary leaders could find themselves co-constructing their vision. Public health and regulatory compliance entities depend on bureaucratic leadership to run effectively.

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BetterLife Closes Acquisition of Second Generation Psychedelic Assets of Transcend Biodynamics LLC

The Pharma Data

With this acquisition we are expanding our product pipeline to include psychedelic therapeutics, incorporating elements of our IP around drug delivery technology in which we already have prototypes developed, which we believe will propel us towards clinical studies relatively quickly. Ahmad Doroudian, CEO of BetterLife.

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Autoinjector: Empowering The Healthcare Industry

Roots Analysis

In the dynamic landscape of the healthcare sector, the evolution of drug delivery systems plays a significant role in transforming the management of chronic diseases. These devices reduce injection anxiety, and are useful for patients who prefer a hands-free drug delivery experience.