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The FDA has hit two compounding pharmacies with warning letters for quality violations and failure to have prescriptions for products they were compounding. Read More
The International Society of Pharmaceutical Engineering (ISPE) is recommending six quality metrics that the FDA should consider collecting from manufacturers as part of the agency’s new quality metrics program. Read More
The drug industry wants the FDA to drop plans to require drugmakers to report manufacturing stoppages that will result in shortages within five days of the stoppage occurring. Read More
The number of drug recalls shot up 17 percent in 2013 compared to 2012, despite the FDA’s best efforts to promote quality-by-design programs and upgrades to facilities. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MRHA) is reminding drugmakers they must report all defects in medicinal products that could lead to a recall immediately upon discovery and provide regular updates on internal investigations into the defects. Read More
Novartis is recalling more than 200 lots of OTC cold and flu drugs distributed in seven countries — a massive market correction by the company beset with quality problems at its OTC plants since 2012. Read More
The FDA wants IND sponsors to stop the practice of routinely using age limits as exclusion criteria for clinical trials and increase the number of patients with multiple chronic conditions included in drug studies. Read More
Pharma companies applying for approval to sell drugs in Canada must submit quality summary documents, certifications of their products’ comparability with monographs of the European Pharmacopoeia and detailed drug master files that comply with the International Conference on Harmonisation’s registration for human use quality standards. Read More