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FDA Issues a Draft Guidance for Content of Premarket Submissions for Device Software Functions

FDA Law Blog

Like the 2005 guidance, this new draft guidance applies to all types of premarket submissions, but now the Agency has specifically added De Novo Classification Requests and Biologics License Applications (BLA). To put the age of the existing guidance into perspective, it was published two years before the first iPhone was released.

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Assisted Living Communities: Podcast with Sheryl Zimmerman, Kenny Lam, and Ken Covinsky

GeriPal

We additionally firmly establish that the song How to Save a Life by the Fray was a product of the aughts (2005, to be exact), not the 90’s ): Enjoy! People saw that there were people who needed to have supportive care, didn’t need to have the level of nursing that was provided in nursing homes, and there was money to be made.

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Well-being and Resilience: a Podcast with Jane Thomas, Naomi Saks, Ishwaria Subbiah

GeriPal

I must admit, though, sometimes it just feels off… inauthentic, as if it’s not a genuine desire to improve our lives as health care providers, but rather a metric to check off or a desire to improve productivity and billing by making the plight of workers a little less miserable. That was like 2005. Ishwaria 43:08 Exactly.

IT 111
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Negotiation and Dispute Resolution: A Podcast with Lee Lindquist and Alaine Murawski

GeriPal

Negotiation Training for Case Managers to Improve Older Adult Acceptance of Services. Prof Case Manag. Dealing with conflict in caring for the seriously ill: “it was just out of the question” JAMA 2005. Getting to Yes: Negotiating Agreement without Giving In by Roger Fisher, William Ury, and Bruce Patton.