If the drug passes all three phases of testing, the company may file a New Drug Application (NDA), which permits the FDA to ascertain that the new drug (or biologic) is safe, reliable, and effective f...If the drug passes all three phases of testing, the company may file a New Drug Application (NDA), which permits the FDA to ascertain that the new drug (or biologic) is safe, reliable, and effective for the indications on the labeling. The FDA employs expert reviewers who examine the test results and determine whether the new drug can be approved.
