8 Common FDA Applications for Drugs & Biologics

The U.S. Food and Drug Administration (FDA) has several types of applications for the approval of drugs and biologics. These applications are part of the regulatory process that ensures the safety, efficacy, and quality of new medicinal products. Here’s an overview of the different types of FDA applications:

1. Investigational New Drug (IND) Application:
   • Before a new drug or biologic can be tested in humans, an IND application must be submitted and approved.
   • The IND includes animal study data and plans for testing the product in humans (clinical trials), ensuring that the trials will not expose participants to unreasonable risks.
2. New Drug Application (NDA):
   • The NDA is submitted for the approval of a new pharmaceutical for sale and marketing in the U.S.
   • It includes comprehensive data from the drug’s clinical trials, including information on the drug’s pharmacokinetics, pharmacodynamics, dosing, side effects, interactions, and manufacturing.
3. Biologics License Application (BLA):
   • Similar to the NDA, the BLA is the request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce.
   • Biologics include vaccines, blood and blood products, cellular and gene therapies, tissues, and certain proteins. The BLA includes data demonstrating that the product is safe, pure, and potent.
4. Abbreviated New Drug Application (ANDA):
   • ANDAs are for generic versions of already approved drugs, where the manufacturer needs to demonstrate that their product is bioequivalent to the innovator drug.
   • Unlike NDAs, ANDAs do not require extensive clinical trials, which significantly reduces the time and cost of bringing a generic drug to market.
5. Supplemental Applications:
   • These are submitted for changes to an already approved NDA or BLA. Changes can include modifications in manufacturing processes, labeling, or formulation.
   • Depending on the significance of the change, different types of supplements may be required (e.g., Prior Approval Supplement, Changes Being Effected Supplement).
6. Emergency Use Authorization (EUA):
   • In certain public health emergencies, the FDA can issue an EUA to allow the use of unapproved medical products or unapproved uses of approved medical products when certain statutory criteria have been met.
   • EUAs have been used, for example, in the case of certain drugs during the COVID-19 pandemic.
7. Fast Track and Breakthrough Therapy Designations:
   • While not applications in themselves, these are special statuses that can be requested for drugs that meet certain criteria, such as addressing unmet medical needs or providing significant advances over existing treatments.
   • These designations can expedite the review process.
8. Orphan Drug Designation:
   • This designation is for drugs that treat rare diseases affecting fewer than 200,000 people in the U.S.
   • It provides certain incentives, like market exclusivity for a period, to encourage the development of drugs for rare conditions.

Each type of application has its specific requirements and processes, reflecting the FDA’s commitment to ensuring that drugs and biologics are safe and effective for their intended uses.