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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
Drugmakers have asked the FDA to think “globally” with the international community as they weighed in on the agency’s draft guidance on established conditions for reporting chemical, manufacturing and control changes. Read More
Ohio Secretary of State John Husted is facing a lawsuit for failing to transmit the proposed Ohio Drug Price Relief Act citizen petition to the state’s General Assembly, as required by the state’s constitution. Read More