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. Pragmatic Compliance LLC 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 submissions. 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.