Drugs of abuse public hearing
This article was originally published in The Gray Sheet
Executive Summary
Input on a March 5 proposed rule to downclassify from Class III to Class I over-the-counter urine sample collection systems for drugs-of-abuse testing will be sought at a June 19 meeting in Rockville, Maryland. William Schultz, FDA deputy commissioner for policy, will direct the meeting. For more information contact the device center's Steven Gutman at 301/594-3084
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.