CDER Issuing More Communication Letters for ANDAs Under Review

 

FDA has recently begun issuing many more “Easily Correctable Deficiency (ECD)” and “Information Request (IR)” letters to generic drug makers over ANDAs that have been submitted to CDER, according to a new generic drug dashboard report. The agency says this is a positive move because the increase in these categories “demonstrates the agency’s commitment to increasing communications with industry. For example, 40% more ECD letters went out in March (632 letters) than in February (450 letters).

 

An industry response to an ECD, FDA says, “requires only a modest expenditure of FDA resources. An applicant should be able to respond to an ECD quickly, as the applicant should already possess or be able to quickly retrieve the information needed for an adequate response to an ECD. Whereas, an IR is used to ask for further information or clarification that is needed or would be helpful to allow completion of the discipline review, it says.