FDA ALTERNATIVE BREAST PROSTHESES DRAFT GUIDANCE ON TESTING
This article was originally published in The Gray Sheet
Executive Summary
FDA ALTERNATIVE BREAST PROSTHESES DRAFT GUIDANCE ON TESTING outlines four potential options for postmarket epidemiologic studies of nonsilicone gel-filled implants, in decreasing order of cost per study subject: a "prospective center-based cohort study of implant recipients"; a "medical record-based retrospective cohort study of implant recipients"; a "questionnaire screening of implant recipients"; and a "mortality screen." The draft guidance will be a topic of discussion at an Oct. 21 FDA workshop in Washington, D.C. ("The Gray Sheet" Sept. 5, In Brief).
You may also be interested in...
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.
Roche Gets Adjuvant ALK+ Lung Cancer To Itself With Alecensa Approval
The US FDA cleared Roche’s supplemental approval request for ALK inhibitor Alecensa in ALK-positive non-small cell lung cancer following tumor resection.