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When an applicant wishes to market its generic drug product in the US, it is required by the federal law that the applicant submits the initial application to the USFDA with all the required supporting data/information. This Application to seek the approval to market the generic product is known as the Abbreviated New Drug Application (ANDA).
Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product performs in the same manner as the branded drug.
Once an ANDA is submitted to the USFDA, it undergoes the “Screening Review Process” during which the Agency determines if the application is substantially complete to be accepted for the review. As per GDUFA II, this determination is made withing 60 calendar days of filing. If the application is determined to be substantially incomplete to be acceptable for review, the USFDA issues a “Refuse to Receive” letter. Since Each application involves substantial application fee and a refuse to receive results in loss of 25% of the total fee amount, it is very important to compile and submit the application which complies to all the statutory requirements. These regulatory requirements are very dynamic in nature, thus it requires the applicant to keep abreast with the current requirements and tracking of them in a regular fashion.
Once the ANDA is accepted for filing, FDA assigns a goal date which as per GDUFA-II is 10 months from the filing date. A goal date is the date by which FDA will act on an application. To act on an application means FDA will issue a Complete Response Letter (CRL), grant tentative or final approval.