STAT

NOVEMBER 17, 2023

They were approved under the FDA accelerated pathway in 2009 and 2014, respectively, for treating a rare form of blood cancer. The  The company’s final study plan was submitted to the FDA in 2022 and is expected to be completed  by 2030 , according to FDA briefing documents published earlier this week.

FDA 100

FDA Documentation 100

European Pharmaceutical Review

AUGUST 3, 2023

Rather than focusing on documentation with the aim to achieve compliance, the initial proposed framework shined a light on problem-solving and therefore the initiation of preventative action as a key part of the process. QMS market to value nearly $4b by 2030 Improving the CAPA process – what does the risk-based framework include?

Documentation 52

Documentation Process Improvement FDA 52

The FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). Under the Administrative Procedure Act, FDA is obligated to address major substantive issues when – and not so much if – it publishes a final rule.

FDA 69

FDA Research Laboratories Documentation 69

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

ISPE

SEPTEMBER 11, 2023

Worldwide Modular Facilities in Pharmaceutical and Biotechnology Industry to 2030 - Impact Analysis of COVID-19.” www.prnewswire.com/news-releases/worldwide-modular-facilities-in-pharmaceutical-and-biotechnology-industry-to-2030 impact-analysis-of-covid-19-301332565.html AAPS PharmSciTech 23, no. 6 (2022):215. 39 PR Newswire.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52