FDA Drug Safety Changes Will Not Affect Oncology Therapies, Agency's Pazdur Says
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's safety overhaul "will not tamper with" drugs for life-threatening conditions, Office of Oncology Drug Products Director Pazdur tells the American Society of Clinical Oncology annual meeting. FDAer suggests the cancer community could provide insight into improved safety surveillance.
You may also be interested in...
AstraZeneca's Iressa Produces Effect In Subpopulation, ASCO Data Show
Initial Phase II study shows 62% response rate in Korean, non-smoking females with non-small cell lung cancer. Identification of Iressa (gefitinib) responders and the role of EGFR mutations are major themes at the American Society of Clinical Oncology annual meeting.
FDA "Drug Watch" Website To Include Three Categories Of Safety Information
The site will reflect information about serious adverse events, patient selection and monitoring, and risk minimization procedures, an FDA draft guidance states. Manufacturers will be notified "shortly before" information about a drug is first posted; agency suggests the site's information will not be used for promotional purposes.
Madrigal’s FDA Approval In MASH Ends Years Of Industry Frustration
As the first approved MASH (formerly NASH) therapy, nearly four years after initially anticipated, Madrigal gets the opportunity to establish a MASH marketplace with Rezdiffra (resmetirom).