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A number of drugmakers got good news from the European Medicines Agency’s Committee for Medicinal Products for Human Use, including two companies looking to have their lung cancer drugs approved in Europe. Read More
A journal article asking the FDA to defy its own policies concerning drug reimportation and mass compounding to combat rising drug prices comes from an unusual source: the agency’s former second-in-command. Read More
With an eye toward patient-focused drug development, the FDA is seeking feedback on a compilation of clinical tools gathered together under a new pilot program. Read More
A European Parliament committee is calling into question the safety of a pilot adaptive licensing pathway that would bypass traditional approval processes by the European Medicines Agency. Read More
The FDA has slapped India’s Cadila Pharmaceuticals with a warning letter for GMP violations — including a lack of quality controls, improper recordkeeping and inadequate investigations — at its Moraiya formulation plant and Ahmedabad API facility. Read More
A federal appeals court has ruled that Caraco Pharmaceutical Laboratories’ assumption that its plants wouldn’t be closed for GMP violations was not legal justification for it to skirt layoff-notice labor laws. Read More
The FDA’s Office of Regulatory Affairs is making progress on its new program alignment and released information on what the new structure will look like. Read More
Illegal conduct in the compounding and dietary supplement industries are two of the Department of Justice’s top three areas of increased focus, a deputy assistant attorney general said Dec. 9, 2015. Read More
Since January 2015, the FDA has issued 16 drug GMP warning letters covering 19 facilities, and more than three-fourths of those letters cited data integrity issues. Read More
To reduce medication errors, CDER on Friday released its revised policies and procedures on proprietary naming of drugs, which are sometimes misidentified because of the way they are spelled or how the names sound. Read More