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What to Expect When you are Expecting…a Government Shutdown

FDA Law Blog

The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown. During the 5-week shutdown in 2018/2019, PDUFA funding was the most robust and could have funded several months of review operations. What does it mean for FDA staff?

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Agitation Podcast Series Episode 3: Pharmacologic management of agitated children

PEMBlog

However, medications can be adjuncts to non-pharmacologic means to help keep agitated children safe from harm. Government. 2019 Mar;20(2):409-418. Epub 2019 Feb 19. 2019 May;20(3):537. 2019 Jul;20(4):688-689. It is also episode 3 in a 5 episode series focused on agitation in children and adolescents.

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Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law Blog

On June 27, 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. That court granted summary judgment to the government on the APA claim and rejected Pfizer’s narrower reading of the AKS, which would require an element of “corrupt” intent to impose AKS liability.

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Agitation Podcast Series Episode 5: Management of the child with mental health problems who is boarded in the ED

PEMBlog

This episode is a co-production of the Emergency Medical Services for Children Innovation and Improvement Center whose mission is to minimize morbidity and mortality of acutely ill and injured children across the emergency continuum. Government. 2019 Jul 22;20(5):690-695. Pediatrics March 2023; 151 (3): e2022057383. Pediatrics.

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Agitation Podcast Series Episode 1: Differentiating organic versus psychiatric causes of agitation and altered mental status

PEMBlog

Why then do we persist with the “is it medical/organic or psych” question? Government. Pediatr Radiol 2019; 49:240. 2019 Mar;20(2):409-418. 2019 Mar;20(2):409-418. Epub 2019 Feb 19. 2019 May;20(3):537. 2019 Jul;20(4):688-689. West J Emerg Med. doi: 10.5811/westjem.2019.1.41344.

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DOJ Re-Brands Guidance Documents

FDA Law Blog

The federal government does its own version of rebranding with each change in administration. The memorandum cites the 2019 Supreme Court decision, Kisor v. Walsh & JP Ellison — Companies often use rebranding to reposition and refocus their business. Wilkie , 139 S.

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The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law Blog

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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