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Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious

FDA Law Blog

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” In February 2010, an oral formulation of BRAVECTO, a medication to treat and prevent fleas and tick infestation in dogs, was the subject of an INAD submitted to the Agency.

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Episode 275: Anti-Racism in Medicine Series – Episode 19 – Reframing the Opioid Epidemic: Anti-Racist Praxis, Racial Health Inequities, and Harm Reduction

The Clinical Problem Solvers

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. This parallels another process, which is the medicalization of human experiences, especially those relating to childbirth and pregnancy. American Medical Association; Manatt Health.

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EMS Intervention to Reduce Falls: Carmen Quatman and Katie Quatman-Yates

GeriPal

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. This is because the presumption that manufacturers can unilaterally make substantive changes to the labeling of an OTC Monograph drug product is false.

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RCT of PC in ED: Corita Grudzen, Fernanda Bellolio, & Tammie Quest

GeriPal

I think that study was really important, especially I think the message that I give people is you can do something as simple as calling a consultation and improve quality of life months later. Do they have documents in the record like medical orders for life sustaining treatment or a healthcare proxy? So that’s great. Absolutely.

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Dementia and high risk surgery: Joel Weissman and Samir Shah

GeriPal

Alex: Today, we are delighted to welcome Joel Weissman, who is a health services researcher and deputy director and chief science officer for surgery at the Center for Surgery and Public Health at Harvard Medical School. And where I’m going with this is even if … Or patient-centered medical home, patient-centered care, right?