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FDA’s Office of Manufacturing Quality will now be involved in evaluating all BLAs and supplements to ensure product quality throughout a product’s lifecycle. 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 FDA cited Novartis’ Vaccines and Diagnostics facility in Liverpool, UK, for lapses in its equipment cleaning and validation processes and inadequate investigations and CAPAs in a Form 483 issued June 11. Read More
The FDA could issue guidance on demonstrating interchangeability between a biosimilar and its reference product by the end of the first quarter of next year. Read More
A drug compounder not approved by the FDA says it is mixing pyrimethamine — the active ingredient in Daraprim — with another drug, folic acid-derivative leucovorin, at a cost of $99 per 100-count bottle to counter Turing Pharmaceuticals’ $750 per pill price on the blockbuster AIDS drug. Read More
Drugmakers facing a European GMP inspection should be prepared to provide complete documentation of active ingredients throughout the supply chain, going back to the starting materials that were used in the synthesis of the APIs. Read More