Write note on NDA and ANDA.
Answers
NDA means New Drug Application. When the sponsor of a new drug believes that enough evidence on the drug’s safety and effectiveness has been obtained to meet the FDA’s requirements for marketing approval, the sponsor submits to the FDA a new drug application (NDA). In other words, when a pharmaceutical company creates a new drug, the company must contact the FDA and demonstrate that the new drug has a particular quality and that the drug is safe and effective. The review is aANDA means Abbreviated New Drug Application. An abbreviated new drug application (ANDA) contains data that, when submitted to the FDA, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called “abbreviated” because they are not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the original drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the public. comprehensive analysis of clinical trial data and other information prepared by the FDA drug application reviewers. A review is divided into sections on medical analysis, chemistry, clinical pharmacology, bio pharmaceutics, pharmacology, statistics, and microbiology.