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The FDA has warned another compounding pharmacy for actions that occurred prior to passage of a new federal law that boosted the agency’s authority over such facilities. Read More
Manufacturers should include effective evaluation and verification studies in their process validation documentation when obtaining biotechnology-derived proteins in the EU, according to a new guidance from the European Medicines Agency (EMA). Read More
The FDA has issued a warning letter to Mexican biologics maker Instituto Bioclon for “significant deviations” of current good manufacturing practices (cGMPs), including failures to ensure adequate environmental monitoring and employee training. Read More
The European Medicines Agency March 11 published the first risk-management plan summary for Piramal Imaging’s molecular imaging agent NeuraCeq (florbetaben (18F)), used to detect ? amyloid plaques in the brain, a protein associated with Alzheimer’s disease. Read More
Indian drug regulators have suspended distribution of three drug products made by Wockhardt, the company announced Wednesday, adding to sanctions it already faces from the FDA and UK regulators. Read More
The European Medicines Agency is tightening stability testing requirements for drugmakers submitting applications for significant post-approval manufacturing changes that involve active substances. Read More
Hospira’s quality struggles continue as the injectable giant voluntarily recalled seven lots of generic anesthetic propofol due a defect that led to metal particles in certain vials. Read More
Indian authorities quietly suspended Ranbaxy’s Toansa facility from exporting active pharmaceutical ingredients to Europe late last month, signaling the country’s new, tougher approach to manufacturing quality violations. Read More
The European Commission is mandating that drugmakers implement a detailed protocol for transferring testing methodology from one lab to another to ensure product quality. Read More
The FDA has banned imports from active pharmaceutical ingredient maker Canton Laboratories, the fourth Indian drugmaker in a month to be put on import alert for poor quality. Read More
An FDA task force Tuesday recommended the agency expand the amount of information about inspections and enforcement that it releases, allowing the public to view a more detailed record of a company’s compliance history. Read More