Types of FDA Applications for Drugs and Biologics

The Electronic Common Technical Document (eCTD) is the standard, accepted electronic format for the following submission types:

  • New Drug Application (NDA)
  • Abbreviated New Drug Application (ANDA)
  • Investigational New Drug Application (IND)
  • Biologics License Application (BLA)
  • Master files: Drug Master File (DMF) and Biologics Master File (BMF)
  • Emergency Use Authorization (EUA)

An eCTD publishing tool is recommended to automatically create the eCTD sequence folder and file structure. FDA does not recommend specific tool vendors, however, they can be located via internet search.

For information on eCTD format, please visit: www.fda.gov/ectd

Types of Applications

Investigational New Drug (IND)

Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA.

New Drug Application (NDA)

When the sponsor of a new drug believes that enough evidence on the drug’s safety and effectiveness has been obtained to meet FDA’s requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA).

The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United States.

Abbreviated New Drug Application (ANDA)

Generic drug applications are called “abbreviated” because they are generally 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 innovator drug).

Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.

Over the Counter Drugs (OTC)

Over-the-counter (OTC) drugs play an increasingly vital role in America’s health care system.
OTC drug products are those drugs that are available to consumers without a prescription.

Biologic License Application (BLA)

Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product.

A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry,pharmacology, clinical pharmacology and the medical affects of the biologic product.

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