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Lots of FDA Guidance, But Few Drug Manufacturing “Remote Interactive Evaluations” (We Would Call Them “Virtual Inspections”)

The FDA Law Blog

Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. Compared with the COVID-centered version of the document released in April 2021, there is very little that is new or different.

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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

The FDA Law Blog

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). However, in our experience, there is a large gap between FDA’s lauding the value of RWE and practice. Congress has recognized the challenges with FDA’s acceptance of RWD and RWE.

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How to get insurance to cover Ozempic for weight loss

The Checkup by Singlecare

Ozempic (semaglutide) is a brand-name injectable prescription medication administered once weekly. It’s in a class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists, approved by the Food and Drug Administration (FDA) to manage blood sugar levels in adults with Type 2 diabetes when combined with diet and exercise.

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Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List)

The FDA Law Blog

Sasinowski — This time last year, we wrote about a long-overlooked FDA statutory authority and wondered if this provision, known colloquially as the “single study plus confirmatory evidence” pathway, was having a moment (previous post here ). Valentine & Frank J.

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The Value of a Medically Integrated Pharmacy to Maximize Cost Avoidance and Reduce Waste of Oral Oncolytic Medications

Pharmacy Times

Materials and Methods Oncology-trained nurses review the charts of all specialty oncology medications that are due to be refilled. The nurses have access to the electronic medical record and perform an extensive medical records review of office notes, labs, scans, pathology, and upcoming appointments.

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The unsustainability of clinical trials and need for transformative change

Pharmaceutical Technology

Research staff can spend a significant amount of time sifting through medical records to find the patients under care that fit incredibly specific trial criteria,” he says. Relying on a on academic medical centers and expecting rural patients to travel or disrupt their lives to join a trial is leading to diminishing returns.