pharmaphorum

DECEMBER 17, 2020

The company’s lead candidate Tenapanor is a targeted, small molecule therapy currently under FDA review. As the pandemic surged this year, the disruption of healthcare systems posed a significant challenge for patients receiving kidney care. Patients who undergo dialysis are some of the most fragile.

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FDA Documentation Patient Care 104

DiversifyRx

JULY 11, 2024

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. If the FDA or another regulator requests DSCSA transaction data, the DSCSA regulations give you up to 48 hours to respond. The original article can be found HERE.

Independent Pharmacies 52

Independent Pharmacies FDA Documentation CPhT 52

The FDA Law Blog

JUNE 21, 2023

As acknowledged in the Strategic Priorities document, certain demographic groups may have limited access to necessary treatments and diagnostics. FDA defines a Home Use Device as “a medical device intended for users in any environment outside of a professional healthcare facility.

Documentation 45

Documentation FDA Patient Care Hospitals 45

Hospital Pharmacy Europe

JUNE 8, 2023

A recent analysis suggests changes to primary endpoints occur frequently in randomised clinical trials in oncology, representing a risk of suboptimal – or even potentially harmful – patient care, together with outcome reporting bias. Rod Tucker investigates what this means for clinicians.

Documentation 52

Documentation Communication Patient Care Hospitals 52

pharmaphorum

DECEMBER 6, 2022

We’re trying to register lifesaving therapies, but we have to collect the data manually, and often the FDA and EMA inspectors have to visit trial sites to validate the data. When I first started working in clinical trials, people were just moving from paper documentation to EDCs,” Peleg says. It’s simply a waste of resources.”.

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Data Entry Communication Hospitals Documentation 98

PharmaShots

JUNE 14, 2023

In Sep 2022, Konica’s Chiropractic Straight Arm (CSA) system received the US FDA’s approval as an X-ray technology allowing diagnosis through visualization of the anatomy. In Jul 2022, DiaSorin’s Liaison MeMed BV test received the US FDA’s approval for its commercial launch across the US.

FDA 56

FDA Hospitals Documentation Patient Care 56

pharmaphorum

AUGUST 19, 2022

But the current surge of data from sensor technologies is outpacing the industry’s ability to collect, store, analyse, protect, and use this data effectively for research and patient care. Sensor Data Standards Toolkit.

Documentation 52

Documentation Patient Care Hospitals FDA 52