FDA Law Blog

JUNE 10, 2024

By Sarah Wicks & Anne K. Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program.

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Provider Electronics Clinical Practice Management 111

PEMBlog

JUNE 10, 2024

Supraventricular tachycardia is really fun to convert. You go do all kinds of vagal maneuvers which are basically heart games. Then there’s the REVERT maneuver – it works great! Search for it and learn it. Or watch this video. Lyrics S V T! A heart rate so fast as fast as can be S V T! EKG super fast rate with no p waves Q R S is narrow, that’s what you will see S V T!

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Medical Utilities IT 52

FDA Law Blog

JUNE 10, 2024

Last month the Department of Justice and the Drug Enforcement Administration submitted a notice of proposed rulemaking to reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. Hyman, Phelps & McNamara, P.C. Director Larry Houck will participate as a panelist focusing on this timely topic in the Food and Drug Law Institute’s (“FDLI’s”) “High Time for a Change: Implications of DEA’s Proposed Marijuana Rescheduling” webinar June 12, 2024, 2:00

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FDA Law Blog

JUNE 10, 2024

By Larry K. Houck — It seems as though we cannot get through a week without hearing about controlled substance diversion by employees at another hospital or healthcare facility. We learned this week that Palomar Health, one of California’s largest healthcare districts, agreed to pay $250,000 to resolve allegations that numerous vials of fentanyl had been diverted from automated medication dispensing machines over a five-month period and that the hospital did not properly dispose of unused fentan

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Management Patient-Centered Hospital Healthcare 59