XTalks
AUGUST 3, 2022
Subscribe to the Xtalks Life Science Podcast to never miss a new episode. Opzelura Vitiligo Med Wins FDA Approval as First Treatment for Repigmentation. The weekly podcast is available for streaming every Wednesday on Spotify , Apple Music and wherever you stream your podcasts.
Advarra
AUGUST 16, 2022
That is part of the responsibility of the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). Department for Health and Human Services (DHHS), prepared guidance on expedited programs for sponsors of orphan drug trials. These centers, in conjunction with the FDA and U.S.
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XTalks
JULY 29, 2021
Their findings: 60 percent of trials included exclusion criteria that could disproportionately apply to these minority participants. This analysis was based on the identification of over 2,700 individual exclusion criteria that the research team organized into 56 categories.
Crucial Data Soutions
FEBRUARY 24, 2020
(CDS), a leading technology provider focused on data collection and clinical trial management, today announced several updates in celebration of its tenth anniversary, including the company’s latest technological development, TrialKit AI, a machine-learning API.
Advarra
MARCH 21, 2023
Staying on top of evolving regulatory requirements for a complex medical device category can be overwhelming, even for well-established life science companies. How do you determine if clinical trials are needed for your device? Think of the intent or purpose for the intended use (e.g.,
XTalks
OCTOBER 7, 2024
Takeda has forecasted continued financial pressure but is banking on new drug trials to stabilize its position. This includes 495 people at its Cambridge, Massachusetts headquarters and 146 at its Lexington campus in the same state.
XTalks
SEPTEMBER 13, 2024
Organizations need to create and share their metrics to foster a culture of continuous improvement and learning across the clinical trials enterprise.
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