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The pharmaceutical and biologics industries aren’t hiding their displeasure with a decision from the Centers for Medicare & Medicaid Services to treat all biosimilars based on the originator product as identical for billing and reimbursement purposes. Read More
The FDA issued eight warning letters to active pharmaceutical ingredient manufacturers during fiscal year 2015 — all of them to non-U.S. companies and all for data integrity issues. Read More
A Texas drug compounder is recalling all lots of its sterile drug products after an FDA inspection found it had not investigated failed sterility tests. Read More
The European Commission released new rules clarifying the responsibilities of qualified persons overseeing global, multisite manufacturing operations and the data they need to collect. 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
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
Observations cited in a Form 483 need to be carefully reviewed, because they represent — at least in the mind of that investigator — conditions that could make a drug adulterated. Read More
The European Medicines Agency conducted 350 good manufacturing practices inspections in the first half of this year — roughly 50 percent more than in the same period a year ago, a new report shows. Read More
The FDA hit another Indian active pharmaceutical ingredients maker with a warning letter after an inspection revealed data integrity issues and significant cGMP violations. Read More
Responding to more than a dozen Form 483 responses from compounders that say they’re not subject to FDA GMP requirements, the agency put compounders on notice outlining enforcement penalties and bulk substance rules that compounders must adhere to. Read More