News from the healthcare data industry
Baker McKenzie United Kingdom February 2 2022 NICE has produced a single guidance development manual, which describes how NICE conducts itself with each step and stage in its evaluation (NICE’s processes) and...
28-Jan-2022 By Jenni Spinner A representative from IQVIA discusses the particulars of the US agency’s new draft document and shares what it might mean for clinical trial data evaluation. Source: HTTPS://WWW.OUTSOURCING-PHARMA.COM/ARTICLE/2022/01/28/NEW-FDA-DRAFT-GUIDANCE-DOCUMENT-GETS-REAL-ABOUT-RWD-USE
Zachary BrennanSenior Editor, Endpoint News Back in late September, the FDA released a long-awaited guidance on how the industry might use electronic health records (EHRs) or medical claims data in...
January 26, 2022 $18.5 million in funding from the Cancer Moonshot will help researchers at USC Norris Comprehensive Cancer Center close the gap in our understanding of colorectal cancer in...
January 24, 2022 04:12 PM Eastern Standard Time WASHINGTON–(BUSINESS WIRE)–Today, the RWE Alliance submitted a substantial comment letter in response to the U.S. Food and Drug Administration (FDA) draft guidance on using...
Changes to the way medicines and other health technologies are evaluated by NICE for use in the NHS were approved by its Board yesterday (19 January 2022). 20 January 2022...
By Tamra Sami PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has undertaken a massive effort to reform its drug and device regulations, and as it pulls into the homestretch with those reforms,...
31 Dec 2021 NEWS Vibha Sharma Executive Summary The UK Medicines and Healthcare products Regulatory Agency has finalized the first part of a series of new guidance documents addressing issues...
Author: Dr. Matthew Roe and Rebecca HancockDecember 2021BackTwitterFacebookLinkedIn Verana Health recently shared comments with the Food and Drug Administration sharing our support for its draft guidance document, “Real-World Data: Assessing...
By Mark McCarty The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has unveiled two guidances for the use of real-world evidence (RWE) in regulatory decision-making. The policy seems limited to pharmaceutical clinical...