The FDA interacts with sponsors throughout the drug development and approval process in order to guide and regulate testing procedure. Official review of a new drug’s safety and effectiveness, however, only begins after clinical trials have been concluded, with the submission of a New Drug Application, or NDA. An NDA contains all of the data that researchers have gathered about a drug through clinical trials, plus manufacturing, labeling, biological, and chemical information to determine the drug’s appropriate use. CDER uses this information to determine whether or not a drug is sufficiently safe and effective to be approved. Biologics License Applications, or BLAs, are similar documents submitted by biologics developers for review and approval.