What does NDA mean in ONCOLOGY

Various documents must be included in an NDA, such as clinical trial data supporting the safety and efficacy of the drug, information on the drug's composition, instructions for use, possible side effects and interactions with other drugs or supplements, manufacturing details, packaging and labeling information, stability tests results and more.

The length of time depends on many factors but typically takes several months to complete all of the necessary documentation. After submission of an NDA, the FDA generally has 60 days to review the application before making a decision as to whether or not they grant approval.

Yes. Depending on if this is the first time the drug is seeking approval from the FDA or if it is being resubmitted after previously being denied, there are three different types of applications--a full NDA for a new drug product; an abbreviated new drug application (ANDA)for generic drugs; and supplemental NDAs (sNDAs) used when requesting changes in already-approved drugs.

Yes. Pharmaceutical manufacturers must generally conduct clinical trials with various participants prior to submitting their NDA for approval by the FDA. These studies evaluate safety, efficacy and dosage accuracy as well as potential interactions with other medicinal products or foodstuffs that could have negative consequences if taken together with certain medications. Q: What happens after submitting a New Drug Application? A: Once an NDA has been submitted to the FDA, including all supplementary materials requested by reviewers at the agency during pre-review meetings and telephone discussions with sponsors within 30 days prior to filing date, their review process begins which may involve further conversations between sponsors/manufacturers and reviewers at agency regarding any additional documents needed or questions in support of their data set or investigational plans before ultimately deciding whether or not they will approve them for marketing in US marketplace.