Fierce Pharma
JANUARY 5, 2024
In fact, the research shows that those who were on semaglutide were less likely to have suicidal thoughts than patients on other diabetes and obesity meds.
The FDA Law Blog
NOVEMBER 6, 2023
Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. Significantly, FDA agrees that the RIEs may be conducted in lieu of an inspection. We should explain what RIEs are.
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The FDA Law Blog
MAY 13, 2024
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.
STAT
SEPTEMBER 13, 2024
Elevance Health’s Anthem Blue Cross Blue Shield requested money from health-care providers and alleged they falsified patient medical records in ways that led the insurer to cover the medications. As with company drug advertisements, social-media posts sponsored by drug makers are required by the FDA to cite the risks.
European Pharmaceutical Review
AUGUST 23, 2022
“At BUSPH, we have been working with our VA colleagues to look at PTSD symptom improvement in routine care using medical records for several years,” said Jaimie Gradus, Associate Professor of Epidemiology at BUSPH and co-principal investigator on the study. However, both have shown only limited effectiveness in reducing PTSD symptoms.
The Checkup by Singlecare
JUNE 28, 2024
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.
Pharmaceutical Technology
JULY 20, 2022
On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. In its announcement, the FDA advised individuals to keep their electronic or printed health records from the past year ready while seeking treatment.
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