Once you have identified a drug or biologic that you want to bring to market, the next step is applying for approval from the US Food and Drug Administration (FDA). There are a variety of different types of applications, each with its own purpose, timing, and requirements. Here’s a look at the five most common types.
Investigational New Drug Application
The Investigational New Drug (IND) application is the first step in the FDA approval process. An IND application is used to gain authorization to start clinical trials. It is not a license to market a drug.
Essentially, the purpose of an IND application is to obtain permission from the FDA to test a new drug in human subjects, with the goal of determining whether it has potential therapeutic use. This process includes ensuring that proper informed consent procedures are followed and informing researchers about any serious side effects or adverse reactions that may occur in some people who take part in these trials. Additionally, ensuring that testing protocols are adequately designed so as not to expose participants unnecessarily to drugs that might be harmful to them and unlikely ever become approved by regulators anywhere else in the world due to their high-risk profiles is part of the process.
New Drug Application
The New Drug Application (NDA) is the most complex of all applications. It must be filed with the FDA before a drug can be legally marketed in the United States and contains all the information about the drug’s chemistry, manufacture, and controls.
The NDA should include:
- Information about clinical studies that have been conducted with the drug
- A discussion of how long you have been manufacturing this product and what has happened during that time period (as well as any problems or issues)
Biologic License Application
The Biologic License Application (BLA) is the most common type of application that a company files with the FDA. A BLA is used to market products, such as drugs and biologics, but not devices. It’s also used for combination products—those that contain two or more different types of regulated entities (drugs, biologics, devices).
Abbreviated New Drug Application
An Abbreviated New Drug Application (ANDA) is a streamlined version of an NDA for drugs that are already approved in other countries.
- For example, if you want to sell your drug in the US with an existing patent, you can file an ANDA at any time while that patent is still valid. You don’t have to wait until the original drug’s patent expires to submit your application.
- If a drug already has approval in another country but it’s not currently approved by the FDA, then you can file an ANDA instead of having to submit an NDA.
Over-the-Counter (OTC) Drug applications are for drugs that are generally recognized as safe and effective, self-administered, and do not require a prescription. OTC applications include:
- Drugs that contain one or more active ingredients in concentrations greater than or equal to 10% by weight
- Self-medicated external homeopathic drug products intended for non-serious diseases such as colds or other minor conditions
Prior Approval Supplements
The FDA may require a Prior Approval Supplement for specific changes. These include alterations to the manufacturing site, product labeling, product description, product specifications (i.e., quality data), and/or to the quality system (e.g., change in an auditor).
There are changes that do not require a Prior Approval Supplement. Those may be submitted as revisions or amendments to an NDA or BLA on a rolling basis at any time during its review process. This includes data generated after approval, information regarding adverse events reported after approval, and other modifications of information contained in an application that do not involve substantial changes in the nature of the article being approved or its use under conditions recommended by us.
Each application has a different purpose, different timing, and its own set of requirements
The IND is a protocol that explains how you will test the safety of your drug or biologic in humans. Once you get an IND approved, you can begin clinical trials.
The NDA is the marketing application that allows FDA to review your drug’s safety and effectiveness for use in humans. It includes information about manufacturing processes and quality control, as well as information about how you plan to distribute the product after approval.
The BLA is used when a company wants to make a minor change (such as adding something new) to an already-approved device or chemical/drug substance. This application also has its own set of FDA requirements, which may differ from those required by other applications like NDAs or ANDAs (see below).
The ANDA is similar to an NDA; however, instead of being submitted by a pharmaceutical company seeking approval on behalf of their own product line (like an existing medication), this type typically comes from another manufacturer who wants to sell generic equivalents once a different company receives initial approval first. Eventually, everyone will have access under fair competition rules once patents expire, though that may not happen until 20 years after the original discovery date.
We hope this article has helped you learn about the various types of FDA drug and biologic applications. Knowing what each type means for your product is vital, ensuring you choose the right one for your needs.
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