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Sun Pharma is in the midst of another quality problem, this time involving a recall of 428,058 bottles of antihistamines and antidepressants after stability testing found issues with the products. Read More
Injectable drug maker Hospira has issued a voluntary recall of dobutamine injection, USP, after a customer complaint of discoloration in a single vial of the heart disease drug. Read More
The FDA slammed biologic manufacturer Greer Laboratories in a warning letter for extensive quality problems, including the presence of pests in its manufacturing plant, and making unapproved allergenic extracts. Read More
Indian drugmaker Cadila Healthcare is recalling more than 10,000 bottles of antihistamine due to a drug mix-up, becoming the latest Indian company to face quality problems. Read More
Injectable drugmaker Hospira has issued a voluntary recall of dobutamine injection, USP, after a customer complaint of discoloration in a single vial of the heart disease drug. Read More
The FDA can exercise flexibility on the quality manufacturing information it requires drugmakers to present under expedited drug approval processes, says a final guidance. Read More
The FDA now has the power to stop any pharmaceutical import it suspects could be adulterated or misbranded, according to a final rule that implements the agency’s new import authority. 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
Drugmakers that are obtaining biotechnology-derived proteins in the EU should include effective evaluation and verification studies in their process validation documentation, the European Medicines Agency says. Read More
The FDA now has the power to stop any pharmaceutical import it suspects could be adulterated or misbranded, according to a final rule that implements the agency’s new import authority. Read More