The FDA Form 2252, central to the regulatory field of pharmaceuticals and biologics, serves as a critical tool for companies to submit their annual reports to the Food and Drug Administration (FDA). As mandated by law, this submission is obligatory for maintaining the approval status of New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), or Biologics License Applications (BLAs). The form, which requires detailed information including drug or biologic names, applicant contact information, types of reports, and specific data on distribution, labeling changes, and updates on manufacturing processes, ensures that the FDA stays informed about significant changes and ongoing post-marketing commitments. Notably, the form allows for the reporting of both NDA and BLA-related information, highlighting the dual focus on both pharmaceuticals and biologics. Failure to comply with this submission requirement can result in severe consequences, such as withdrawal of the approved drug or biologic from the market. The structured process outlined on the form, including the submission of accompanying documents, underscores the importance of accurate and timely reporting by license holders to continuously monitor the safety, efficacy, and quality of medicines available to the public.
| Question | Answer |
|---|---|
| Form Name | Form FDA 2252 |
| Form Length | 1 pages |
| Fillable? | No |
| Fillable fields | 0 |
| Avg. time to fill out | 15 sec |
| Other names | form no fda 2252, how to fill form 2252, form 2252, fda form 2252 fda |