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President Barack Obama Nov. 27 signed into law a bill that establishes both a nationwide track-and-trace requirement for prescription drugs and a system of voluntary FDA oversight of compounding pharmacies. Read More
The European Medicines Agency on Tuesday launched a collaborative five-year program aimed at developing a pan-European framework for monitoring vaccines throughout their lifecycle. Read More
Congress rejected the FDA’s call for mandatory oversight of compounding pharmacies, passing legislation Nov. 18 that instead allows compounders to volunteer for agency oversight. Read More
The FDA plans to shift its focus during facility inspections away from examining documentation, such as standard operating procedures, and place more emphasis on a facility’s operational metrics. Read More
A North Carolina pharmacy is recalling all of its sterile compounded drugs distributed within the Tar Heel State and ceasing production of sterile products altogether after an FDA site inspection. Read More
The Department of Justice is investigating a Phase III study of AstraZeneca’s (AZ) heart drug Brilinta, which analysts and experts say could revolve around allegations of data falsification. Read More
While the number of FDA inspections of clinical investigators has grown in the last 30 years, the proportion of objectionable findings has dramatically decreased, says a new report. Read More
The FDA plans to shift its focus during facility inspections away from examining documentation, such as standard operating procedures, and place more emphasis on a facility’s operational metrics. Read More
The FDA has handed Daiichi Sankyo an untitled letter for making claims in a brochure that two of its hypertension treatments helped lower blood pressure in patients with severe hypertension, despite a lack of substantial supportive evidence. Read More