FDA and Niyam

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective medicine and drugs are available to improve the health of all people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.Niyam is proud to support the CDER’s Generic Drug Review System.

Generic drugs are copies of innovator or brand-name prescription drugs and make up about 88 percent of prescriptions filled in the United States. All brand-name drugs must demonstrate their safety and effectiveness through expensive and time-consuming research and development programs, including clinical studies. In contrast, generic drug developers can use data from their brand-name counterparts, resulting in much less expensive development programs and affordable access to treatments for many patients and consumers. Niyam provides support to CDER team to make sure that every generic drug is safe, effective, high quality and substitutable to the brand name drug.

Our support of CDER is helping in conducting a thorough examination of the data submitted by the generic drug company and the evaluation of information obtained by our investigators while inspecting the related testing and manufacturing facilities. With these reviews, patients can be confident in the generic drug they are taking. Such findings are delivered to patients and stakeholders through our co-designed business portal hub for users to access information, manage review-related activities, and complete assigned tasks for the Information Request process. The portal and the new process will improve the users experience and bring efficiencies to the drug review process.

Niyam also supports the program in evaluating any proposed changes to the generic drug product after it is approved. Significant changes require review and approval by FDA before the changed generic drug is released to patients. Our work not only ensures a more streamlined, effective drug review process, it also helps improve overall patient confidence in generic drugs. We are humbled to assist the FDA in these endeavors and will continue to apply our talents for a better, safer market.