Device GMP violation rate continues downward trend, dropping to 20% in FY 1995.
This article was originally published in The Gray Sheet
Executive Summary
DEVICE GMP INSPECTION VIOLATION RATE DROPS TO 20% IN FY 1995, Marge Hoban, chief of the Field Programs Branch within FDA Center for Devices and Radiological Health's Office of Compliance, reported May 7 at a Regulatory Affairs Professionals Society meeting in Rockville, Maryland. Of 1,662 GMP inspections conducted by FDA in fiscal year 1995, 20% (340) were found to be violative, continuing a three-year decline in the percentage of violative GMP inspections. In FY 1994, 23% of the 1,942 GMP inspections found violations, compared to 24% of inspections in FY 1993 and 26% in FY 1992.
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.