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
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.
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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Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something.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.
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 FDA Law Blog
OCTOBER 18, 2023
Lenz, Principal Medical Device Regulation Expert — Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission. electronic health records, claims). By Adrienne R.
pharmaphorum
OCTOBER 12, 2022
According to the FDA, in 2020 around three quarters of clinical trial participants in the US were white, while just 11% were Hispanic, 8% were Black, and 6% were Asian. The app will provide reminders for appointments and other healthcare services, and also serve as a conduit to enable participation in research studies.
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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