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Empowerment Self-Defense Arms ED Staff Against Rising Workplace Violence

Physician's Weekly

Created in consultation with emergency medicine professionals, the show aims to raise awareness and provide validation to frontline healthcare workers everywhere. The Warner Bros. The series dramatizes what surveys confirm: violence is not an exception in the ED—it is part of the environment.

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. However, the 2014 Guidance cannot be ignored entirely. By Charles G. Raver & James E. Valentine & Ellis Unger & Frank J.

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

FDA Law

Plaintiffs performed the necessary studies on BRAVECTO and filed an NADA on April 8, 2014; FDA approved the NADA on May 15, 2014. s Motion for Summary Judgment finding that FDA failed to provide fair notice to plaintiffs of the need to submit an NCIE rather than an INAD to trigger the start of the testing phase. When the U.S.

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When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

FDA Law

For instance, the December 2024 guidance goes beyond the 2014 Expedited Programs for Serious Conditions Drugs and Biologics guidance (the last to deal substantively with accelerated approval) to describe FDAs expectation that sponsors take a proactive approach to ensuring confirmatory trials are completed within specified timelines.

IT 105
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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law

Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown.

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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law

Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown.

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My 15-Year Journey With Lithium Disilicate

CDOCS

png]<br /> <em><span style="font-size:11px;">​Figure& 1:& <span data-contrast="auto" xml:lang="EN-US">A life-long bruxer, this patient presented with lost teeth in the posterior and compensatory eruption of lower anterior teeth.</span>& png] [image:10.png]​<br