FDA’s 2024 Pharmaceutical Quality Report Highlights Key Global Trends

The U.S. Food and Drug Administration’s Office of Pharmaceutical Quality (OPQ) has issued its seventh annual State of Pharmaceutical Quality Report for fiscal year 2024, offering a detailed review of manufacturing, inspections, product approvals, and compliance outcomes. According to the findings, the FDA database listed 4,619 drug manufacturing sites worldwide, with 41% located in the United States. Inspections climbed to 972—marking a 27% rise from FY2023—including a record 198 under Mutual Recognition Agreements. Notably, over 62% of inspections were conducted abroad, the highest proportion recorded.

The product portfolio also grew to 14,168 Abbreviated New Drug Applications (ANDAs), 3,625 New Drug Applications (NDAs), and 383 Biologics License Applications (BLAs), with biosimilars increasing by 47%. Postmarket quality defect reports dipped slightly to 16,837. Enforcement actions included 75 new import alerts, 421 product recalls—the lowest in five years—and 105 warning letters, the largest number since FY2019, underscoring strengthened regulatory oversight.

03-09-2025