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FDA’s Proposal to Remove Oral Phenylephrine from the OTC Monograph Isn’t a Surprise but What is Left “Over-the-Counter”?

FDA Law Blog

As dictated by the process provided for in the 2020 CARES Act, FDA announced issuance of the proposed order in a Federal Register notice and published the proposed order itself on FDA’s website. Notably, the proposed order provides that the order, if finalized, will become effective one year after the final rule is published.

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Peripheral Arterial Disease and Foot Wounds

Vascular Physician

· Diabetic management is important in preventing the progression of disease. · Encourage smoking cessation and help provide smoking cessation resources. · Ensure appropriate hypertension management and medication. 2005; 1(1):75-84. Smokers have four times the risk of developing PAD as nonsmokers.

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Hyman, Phelps & McNamara, P.C. Names Jeff Grizzel Chief Marketing Officer

FDA Law Blog

HP&M), a leader in providing legal and regulatory support to the life sciences industries, today announced the appointment of Jeff Grizzel to the newly created position of Chief Marketing Officer (CMO). Ellison, HP&M’s Managing Director. Hyman, Phelps & McNamara, P.C. (HP&M),

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FDA Issues a Draft Guidance for Content of Premarket Submissions for Device Software Functions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Like the 2005 guidance, this new draft guidance applies to all types of premarket submissions, but now the Agency has specifically added De Novo Classification Requests and Biologics License Applications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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A podcast episode about laryngomalacia

PEMBlog

Learn all about diagnosis and management of this common problem in this brief podcast episode. 2005 Nov;128(5):3391-7. So this management is conservative, includes upright feeding, antireflux therapy, so alterations to how you Feed, burp, and position. Otolaryngol Head Neck Surg. 2012 Oct;147(4):619-26. 2016 Apr;83:78-83.

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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.

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