FDA reg review targets three-quarters of rules for deletion or modification.
This article was originally published in The Gray Sheet
Executive Summary
FDA REG REVIEW TARGETS THREE-QUARTERS OF AGENCY RULES for deletion or "reinvention," FDA Office of External Affairs Deputy Commissioner Sharon Smith Holston said June 21 at the National Association of Pharmaceutical Manufacturers mid-year meeting in Washington, D.C. Over the past year, FDA has conducted a line-by-line review of its regulations and found that over 1,300 pages could be deleted or modified. The review excluded rules concerning product approvals and classifications.
You may also be interested in...
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
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.