Containment Marketing Radiology 
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.
XTalks
APRIL 27, 2021
The US Food and Drug Administration (FDA) has authorized marketing of a new neurological rehabilitation device to assist in maintaining or increasing range of motion as part of muscle re-education in patients undergoing stroke rehabilitation. The device is approved for use in patients 18 years of age and older.
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XTalks
APRIL 6, 2021
It was approved under the Premarket Approval (PMA) pathway, which is the most stringent type of device marketing application required by the FDA. The Harmony pulmonary valve is implanted using a thin catheter with a collapsed Harmony valve on the end.
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.
The Pharma Data
MARCH 24, 2021
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.
pharmaphorum
MARCH 11, 2021
The UK’s perceived failure to contain the initial spread of the virus was, we were told, in part due to a lesser focus on test and trace procedures than in some other countries, and that was down to us not having a tradition of diagnostics in this country. Over a year ago PCR testing was not a familiar term but is now known by general public.
XTalks
MARCH 30, 2021
An innovative new non-surgical medical device called the portable neuromodulation stimulator (PoNS) has received marketing authorization from the US Food and Drug Administration (FDA) as a treatment to help improve gait in patients with multiple sclerosis (MS). MS affects patients differently with respect to both symptoms and their severity.
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