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Episode 49 – Clinical unknown with Drs. Saman Nematollahi and Jennifer Babik

The Clinical Problem Solvers

[link] Episode description Dr. Saman Nematollahi presents a clinical unknown to Dr. Jennifer Babik Download CPSolvers App here Show Notes Dr. Jennifer Babik Jennifer Babik is an Associate Clinical Professor in the Division of Infectious Diseases at UCSF.

Clinic 52
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Biogen agrees to pay $900 million in largest FCA Settlement Ever Secured without Government’s Intervention

FDA Law Blog

HHS noticed an increasing trend of illegal kickbacks in connection with speaker programs and in November 2020, the Office of Inspector General issued a Special Fraud Alert on the topic. The Alert described several factors that could potentially violate the antikickback statute.

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PhRMA Code Revised in Response to OIG Special Fraud Alert on Speaker Programs

FDA Law Blog

These revisions appear to be responsive to a November 16, 2020 Special Fraud Alert issued by the Office of Inspector General at the U.S. Department of Health and Human Services (OIG) (see our blog post on this Special Fraud Alert here ). not friends, significant others, or family members of a speaker or invitee).

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While the Orphan Battles Wages, Jazz Takes a Loss

FDA Law Blog

Though Jazz alleged that the Sleep Team consultation departed from OOPD’s standard operating procedures, the Court found this unsupported by the Administrative Record. It found that the Review Division’s initial decision was “preliminary.” Black Ball Freight Serv. , 532, 539 (1970) (cleaned up).

Clinic 111
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You don’t need X-Rays to tell if a child is constipated

PEMBlog

Special thanks to Dr. Stephen Freedman, from the University of Calgary, for reviewing this post as well – he brought some practical feedback to the table. Xrays don’t help in figuring out whether or not a child is constipated and can sometime lead to incorrect conclusions about where pain is coming from.

Diagnosis 122
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Caring for Patients with Duchenne Muscular Dystrophy in the Emergency Department: A Problem-Based Approach

PEMBlog

Duchenne Muscular Dystrophy (DMD) is a complex and progressive disease requiring highly specialized care, especially in emergency situations. When patients with DMD present in the Emergency Department (ED), an understanding of the nuanced aspects of their care is essential for optimal management.

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Conference Notebook: Reporting from FDLI’s 2023 Enforcement, Compliance, and Litigation Conference

FDA Law Blog

There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention. Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week.