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Industry questioned whether the FDA has the legal authority to enforce its quality metrics guidance during a public meeting on the draft document. Read More
IPEC-Americas is urging excipient makers to follow its voluntary guideline on stability testing in the wake of recent requests by foreign regulators for stability data. Read More
With more than 80 percent of APIs coming into the U.S. from foreign sites, the FDA is stepping up its enforcement activities to better manage global supply chains. At the same time, India and China are also expanding their inspection teams. Read More
Drugmakers have just over a year to comply with new Canadian regulations requiring evidence of GMP compliance at foreign facilities that make active pharmaceutical ingredients. Read More
The European Medicines Agency issued draft guidance last month on the manufacture of finished dosage forms, clarifying the information drugmakers should include in the quality section of the common technical document in a premarket application. Read More
IPEC-Americas is urging excipient makers to follow its voluntary guideline on stability testing in the wake of recent requests by foreign regulators for stability data. Read More
Sipra Labs landed an FDA warning letter for major cGMP violations, including failure to investigate batch discrepancies and failure to establish and document testing methods. Read More
Drugmakers have just over a year to comply with new Canadian regulations requiring evidence of GMP compliance at foreign facilities that make active pharmaceutical ingredients. Read More
Beleaguered Indian generics maker Wockhardt is conducting its third U.S. recall since the end of April — this time pulling 162,142 cartons of drugs used to treat high blood pressure and ulcers. Read More
Drugmakers in the EU have less than eight months to conduct risk assessments of all the excipients they use, under good manufacturing practices guidelines imposed by the European Commission. Read More