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FDA Publishes Final Rule to Amend and Reduce Regulatory Burden on Outdated and Duplicative Requirements as They Pertain to Radiological Health Regulations

FDA Law Blog

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. By Véronique Li, Senior Medical Device Regulation Expert & Allyson B.

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Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

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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How AL/ML based solution can help extract clinical data from Source and CRF documents in a clinical study

Cloudbyz

Understanding Source and CRF Documents Source documents refer to any documentation that provides original information about a patient, including medical records, physician’s notes, laboratory reports, and radiology reports. On the other hand, CRFs are electronic forms used to collect and manage clinical data in clinical trials.

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Is ASCA worth it? FDA’s Accreditation Scheme for Conformity Assessment

FDA Law Blog

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.

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Key Items Auditors Look for When Reviewing an Investigator Site File

Advarra

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. Make sure they are signed and dated.

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AZD1222 US Phase III primary analysis confirms safety and efficacy

The Pharma Data

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. JPEO-CBRND.

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AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis

The Pharma Data

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. JPEO-CBRND.

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