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Vitalife received an FDA warning letter after an inspection revealed violations of the agency’s cGMP rules. The agency also challenged claims made on Vitalife’s website related to three of its products. Read More
The FDA has finalized a rule that will require pharmaceutical companies to electronically submit, list and register information on finished drug products and active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. Read More
Applications for generics of Johnson & Johnson’s Risperdal should contain characterization data on the reference product and the copycat version, the FDA says. Read More