FDA Draft Guidance (Part I)

What is Metabesity and why you should know about it

Coined by Kinexum's executive chairman Sam Fleming, "Metabesity" refers to a constellation of diseases and conditions of chronic aging: Diabetes, obesity, cardiovascular, neuro-degenerative diseases, cancer, and the aging process itself. Emerging science suggests a common mechanisms behind them which, if true, raises the possibility of common solutions. Metabesity is a conference that's dedicated to examining prevention and treatment, chronic and acute diseases. It's focused on individual diseases and extension of "health span;" that is, the period of life span spent free of major diseases. The second Metabesity conference, a two-day conference in Washington, DC, will be October 15-16, 2019. Learn more at metabesity2019.com.

FDA Draft Guidance (Part I)

If you have an FDA submission, you must check the FDA draft guidance database – or you might find yourself in a situation like Michelle Lott's client.

FDA Draft Guidance (Part II)

If you have an FDA submission, you must check the FDA draft guidance database – or you might find yourself in a situation like Michelle Lott's client.

The time-buying MDR trick you need to hear immediately

The Medical Devices Group presents me, Joe Hage [https://MedicalDevicesGroup.net], along with regulatory and quality expert, Michelle Lott [https://leanraqa.com/about/]. We're talking today about May 26, 2020 – the date by which medical device manufacturers active in Europe will have to be fully compliant with the EU MDR, the European Medical Device Regulation. Or will they? During the conversation we stumble upon a significant idea we hope many of you will seize immediately! Here's that conversation.

What's the role of Sales today? with Ted Rubin

My client has thousands of leads from whitepapers and webinars and Sales can't convert them.  Internationally renown keynote speaker Ted Rubin happens to be a personal friend for 20 years now. (I was Director of Relationship Marketing to his Director of Sales at 1-800-FLOWERS.COM back in 1999.) When he last visited, we talked about why Sales is having so much trouble with marketing's leads and, ultimately, what sales should be doing today.