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Katrina’s Blog™

Insightful News and Commentary

On leadership, product innovation, talent cultivation, and ecosystem development across drugs, devices, diagnostics, and digital health tools.

Join us as we explore the latest trends and share expert insights to help you navigate the ever-evolving landscape of healthcare innovation.

Let’s embark on this journey of transformation together!

Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)

Feb 18, 2020 |

Chapter 1 - What is a Coronavirus? A coronavirus is a virus that typically causes respiratory symptoms in affected persons. It’s name comes from the tiny projections extending from the membrane that contains the viral DNA, which have the appearance of a crown, or...

For Rare Disease Day 2020 – An Article

Feb 13, 2020 |

As we approach Rare Disease Day this year (February 29th), I’d like to share this PharmaVOICE article on the impact of rare diseases and the efforts underway to address these challenges. As the article notes, while these diseases may be rare because they individually...

2020 Good for Pharmaceuticals and Life Sciences Deals?

Feb 11, 2020 |

There’s a lot of investment capital floating around out there, and the Pharmaceuticals and Life Sciences (PLS) sector could benefit this year. According to a report by international accounting firm PwC, there’s considerable money and investment interest in the space,...

FDA Sponsors Innovation in Sterilization Technologies

Feb 4, 2020 |

Regular readers will recall my post earlier this year on the shutdown of a Sterigenics plant in Illinois using ethylene oxide to sterilize medical devices due to repeat environmental emissions of the sterilant, which is known to cause cancer. The shutdown continues...

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Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)

Apr 28, 2020 |

Chapter 13 - NIH Foundation is Coordinating a Global Research Effort This month, NIH launched a public-private partnership to develop an international strategy for the research on the COVID-19 pandemic. Part of the “part of the whole-of-government, whole-of-America...

Device Submissions Are Now All Electronic

Apr 23, 2020 |

eSubmitter Tool In December, the FDA issued a final rule revising all the regulations for medical device regulatory submissions to replace paper with electronic copies. An update to the eCopy Guidance was issued with the rule, along with updates to guidance on...

Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)

Apr 21, 2020 |

Chapter 12 - Quarantine Reading List - Leadership It's clear we will need innovation and leadership to overcome the health and economic challenges posed by the pandemic to our businesses and community. While you are staying home to stay healthy, make a change to your...

Focus on Women’s Health at the FDA

Apr 16, 2020 |

Recent evidence points to an increased attention on women’s health issues at the FDA. During the FDA’s 2019 Science Forum held in September, Dr. Beverly-Lyn Cook of the National Center for Toxicological Research discussed sex and gender differences in health and...