Remove Containment Remove Drugs Remove Radiology Remove Regulation
article thumbnail

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.

article thumbnail

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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. Keep data consistent with the source.

article thumbnail

First Non-Surgical Heart Valve Wins FDA Approval for Severe Pulmonary Valve Regurgitation

XTalks

The US Food and Drug Administration (FDA) has granted approval to the world’s first non-surgical pulmonary valve to treat severe pulmonary valve regurgitation, a condition often resulting from congenital heart disease. Related: First AI-Guided Ultrasound for Cardiac Imaging Approved by Regulators.

article thumbnail

The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Exosomes are extracellular vesicles that contain molecular cargoes (such as various proteins, RNAs and DNAs) specific to the origin cell.

article thumbnail

COVID-19 Pandemic Coverage

XTalks

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. Drugs and Vaccines. The most promising news about any drug thus far in the pandemic just came out of the UK where Southampton researchers together with Synairgen showed that an inhaled form of interferon-? Drugs, Vaccines and Masks. percent in 2021.

article thumbnail

Sequana Medical Appoints Two Additional Experts as Heart Failure Scientific Advisors

The Pharma Data

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.