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The FDA will create a pharma-only enforcement unit that promises more consistent inspections and enforcement decisions with fewer bureaucratic hurdles for investigators to issue warning letters. Read More
The FDA and European Medicines Agency (EMA) have launched a new information-sharing initiative they hope will coordinate and speed international responses to drug safety problems. Read More
Concerns with particulates in injectable drugs is plaguing Agila Specialties again as the Mylan unit Feb. 19 revealed that its Polish plant is at the center of a recall of an anesthetic product. Read More
Porcine trypsin (PTy), a starting material used in biologic drugs, should be tested just after it is produced to ensure material from a single infected pig doesn’t enter production batches, EU regulators say. Read More
Compounding pharmacies have flooded the FDA with hundreds of comments seeking to protect access to bulk drug substances they use to make products. Read More
The FDA and European Medicines Agency (EMA) are extending for two years a pilot program for joint reviews of quality-by-design (QbD) applications, saying the program has helped both agencies develop guidance in this area. Read More
Sagent Pharmaceuticals is the latest drugmaker to recall products with leaky containers, notifying healthcare providers that two lots of its Zoledronic Acid Injection product may not be sterile after finding that four premix bags had been compromised. Read More
Endo Pharmaceuticals has overcome three complete response letters for its low testosterone treatment Aveed, winning FDA approval for the injectable with a robust risk mitigation program. Read More
After six years of uncertainty, the FDA has lifted a clinical hold on trials of Oxygen Biotherapeutics’ Oxycyte intravenous emulsion, reviving hope for the drugmaker’s traumatic brain injury treatment. Read More