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The FDA’s crackdown on compounders continues with two pharmacies receiving warning letters for compounding drugs without a prescription, mixing an unapproved drug ingredient into compounded products and failing to maintain sanitary facilities. Read More
To help improve drug safety and quality, the FDA and other countries’ drug industry regulators are considering forming a global authority dubbed the International Coalition of Medical Regulatory Authorities, Commissioner Margaret Hamburg says. Read More
OTC drugmaker Advance Pharmaceutical has landed in hot water with the FDA again, getting another Form 483 for various quality issues including a lack of data integrity practices. Read More
The FDA has warned an Indian active pharmaceutical ingredient manufacturer for a laundry list of severe quality violations, such as failing to test batches and losing records. Read More
Just four months after gaining new authority over compounders, the FDA is facing accusations from lawmakers and the compounding pharmacy lobby that it is overreaching its new role and retroactively applying a new federal law. Read More
The FDA is scaling back the number of routine quality inspections it plans to conduct in the U.S. each year by 40 percent in favor of conducting more inspections overseas. Read More
The HHS Office of Inspector General (OIG) this year plans to analyze the findings from FDA inspections of generic drugmakers’ facilities to determine the effectiveness of inspections on ensuring the quality of generic medicines. Read More
The FDA has warned GlaxoSmithKline subsidiary SmithKline Beecham over its failure to adequately address contamination of drug ingredients manufactured at its Currabinny, Carrigaline, Cork, Ireland, plant. Read More
Although great strides have been made by Chinese officials to improve the quality of drugs made in the country, more needs to be done, according to U.S. regulators and drug safety advocates. Read More
The FDA has closed out a warning letter issued to West-Ward Pharmaceuticals after the generic drugmaker completed a two-year overhaul of parts of its quality system. Read More