Generic Drug Application – ANDA Submission Process

ANDA submission process is a critical part of the regulatory approval process. ANDA should be prepared as per the FDA’s recommended format. FDA has established very stringent guidelines for ANDA filing, and any minor mistake may result in the “Refusal to Receive” (RTR). RTR may cost 25 % of the application fee, and ANDA should be submitted again, which will delay the approval process. In the case of Paragraph IV ANDA applications, applicants may loose 180 exclusivity.

The actual ANDA filing process begins at the stage of product development. It is crucial that ANDA applicants to make sure they have developed the formulation to meet FDA’s requirements such as IIG, Q1, Q2, the appropriate particle size of the API, and RLD /RS identification. Any mistakes during the product development stage will be a significant setback for the ANDA filing process and may result in financial loss before the product development stage applicant should obtain necessary clarification from FDA through a controlled correspondence process.

Selection of drug substance (API) source in one of the critical requirements for ANDA. The applicant should make sure the DMF holder is ready to pay facility pay, and the DMF name appears in the “DMF available for reference.” list.

Failure to identify the appropriate drug substance source may cause significant delay and impact the formulation. The selection of excipients and primary packing is also an important aspect of the ANDA approval process.

Identifying contract testing labs and outsourced facilities is an essential factor for ANDA approval, since the delay in the contract testing facility compliance may result in a significant delay in the ANDA approval process.

Foreign companies are also required to appoint US Agent for the ANDA filing process. U.S Agent plays a vital role in the ANDA approval process. Since the FDA communicates with foreign companies through US Agent, it remains the US Agent’s responsibility to promptly communicate between the FDA and foreign companies. Delayed communication from U.S Agent may impact your ANDA approval process.

Abbreviated New Drug Application – or ANDA submission is the process for generic drug approval by the FDA. The ANDA regulatory approval process is highly complex and can involve a considerable investment of time and money.

Changes in the Generic Drug User Fee Act – the legislation for drug regulation in the United States – mean that the FDA has adopted very stringent guidelines for the ANDA filing process and looks for detailed information, including technical and eCTD requirements, ahead of acceptance. Companies must demonstrate that they have implemented the regulatory requirements from the very beginning stage of product development. Time to approval depends on both the quality of the information and how it is presented.

Given the challenges, companies should carefully evaluate a partner to support them through the process and avoid significant delays. FDAbasics can provide Abbreviated New Drug Application services that help companies for generic drug approval in the USA. Our complete solution includes review, technical gap analysis, and eCTD submission to the FDA. Our support draws on our in-depth knowledge and experience in handling the ANDA submission process. Our services include handling controlled correspondence, citizen petition filing, pre-submission meetings, labeling review, cGMP audits, and all other assistance required for generic drug approval.