ANDA submission process is critical part of regulatory approval process. ANDA should be prepared in the FDA recommended format. FDA has established very stringent guidelines for ANDA filing and any minor mistake may results 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 case of Paragraph IV ANDA applications , applicants may loose 180 exclusivity.
Actual ANDA filing process begins at the stage of product development, it is important that companies should make sure they have developed the formulation to meet FDA’s requirements such IIG, Q1,Q2 , appropriate particle size of the API and RLD /RS identification. Any mistakes during product development stage will be big setback for ANDA filing process and may result in the financial loss. Before product development stage applicant should obtain required clarification from FDA through controlled correspondence process.
Selection of drug substance (API) source in one of the important requirement for ANDA. Applicant should make sure DMF holder is ready to pay facility pay and DMFs is in the list published by “DMF available for reference”. Applicants failure identify the appropriate drug substance source may cause significant delay and impact the formulation. Selection of excipients and primary packing is also important aspect of ANDA approval process.
Identification of contract testing labs and outsourced facilities is important factor for ANDA approval , since delay in the contract testing facility compliance may result significant delay in the ANDA approval process.
Foreign companies are also required to appoint U.S Agent for ANDA filing process. U.S Agent plays very important role in the ANDA approval process. Since FDA communicate with foreign companies through U.S Agent , it remains U.S Agent responsibility to promptly communicate between FDA and foreign companies. Delayed communication from U.S Agent may impact 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 look for detailed information, including technical and eCTD requirements, ahead of acceptance. Companies must demonstrate that they have implement the regulatory requirements from the very beginning stage of product development. Time to approval depends on the both the quality of the information and how it is presented.
Given the challenges, companies should take time to evaluate a partner to support them through the process and avoid major delays. FDAbasics can provide Abbreviated New Drug Application services that takes our clients from development to generic drug approval. 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 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.
Remember: any small error in generic drug application may result in a Refusal to Receive (RTR), meaning that the ANDA process has not been successful. Companies will lose 25% of their application fee and have to pay again to resubmit their ANDA. Take the time to choose the right regulatory partner to avoid financial loss and delays to product approval.