FDA Law Blog
FEBRUARY 15, 2023
By Véronique Li, Senior Medical Device Regulation Expert & Allyson B. Mullen — Sections of the radiological health regulations have been updated with the goal of lessening regulatory burdens. The regulations contain many requirements that are over 30 years old. 360ii, 360kk(a)(1), and 360nn(b))).
XTalks
MAY 13, 2022
A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy.
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FDA Law Blog
JUNE 28, 2023
Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.
Advarra
APRIL 30, 2024
Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. For example, most hospital radiology technicians are trained to perform scans for the hospital and/or PI for clinical trials based on the information in the test requisitions. Keep data consistent with the source.
XTalks
APRIL 6, 2021
Related: First AI-Guided Ultrasound for Cardiac Imaging Approved by Regulators. It is based on the FDA’s determination that the PMA application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s).
XTalks
NOVEMBER 7, 2022
“Prospective clinical trials are needed to explore whether changing therapy based on ctDNA dynamics prior to radiologic or clinical progression will improve outcomes compared to our current standard,” added Dr. Bahassi. Regulators may ask at some point to provide that documentation, so it’s important to track that across the study.
The Pharma Data
OCTOBER 14, 2020
Udelson, MD is Chief of the Division of Cardiology at Tufts Medical Center and Professor of Medicine and Radiology at Tufts University School of Medicine. Forward-looking statements This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Source link.
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