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Observations cited in a Form 483 need to be reviewed carefully, because they represent — at least in the mind of that investigator — conditions that could make a drug adulterated. 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
The FDA has hit three more compounders — two in California and one in North Carolina — with warning letters, bringing to 25 the number of warnings issued to this industry this year. Read More
Turing Pharmaceuticals has flip-flopped on its decision to reduce the list price of Daraprim, instead offering discounts of up to 50 percent to hospitals, as well as other minor adjustments to help patients afford the drug, which has skyrocketed in price from $13.50 a pill to $750. Read More
Par Pharmaceutical’s efforts to litigate its way to a generic version of Adderall XR ended with a whimper Tuesday, after a federal judge barred the company from challenging Shire’s patents on the drug. Read More