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The FDA said its Center for Drug Evaluation and Research and the Office of Prescription Drug Promotion issued 47 warning letters last year, compared with 52 in 2014. Read More
Heparin is back in the news, after France’s National Agency for Medicines and Health Products Safety issued a GMP noncompliance statement to China’s Dongying Tiandong Pharmaceutical, which manufactures the active ingredients of Lovenox and Heparin. Read More
Arlington, Texas-based dietary supplement maker Waisted with Lucy was stuffed with violations, as an FDA warning letter dinged the firm for the sale of unapproved and misbranded drugs. Read More
A new report pushes states to agree on common standards for traditional compounding operations and recommends a series of best practices for all to follow. Read More
A new analysis of state regulatory controls on compounding operations has found significant variance in their oversight and enforcement of traditional compounding operations. Read More
The FDA is urging two Florida compounders to reassess their operations after finding significant issues with GMPs and sterile drug practices during inspections. Read More
Two dietary supplement makers — Puerto Rico-based Majopa Industries and ATS Labs of Houston, Texas — were hit with FDA warning letters over the manufacture of adulterated products. Read More
The FDA has slammed yet another Indian drugmaker for data integrity issues: This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Read More