Types of Drug and Biologic Submissions

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Compliance & Regulatory: Biopharma
CRO Consulting
Guidelines & Standards
This week's Proxima Weekly Briefing delves into the world of drug and biologic submission types. Joel Reid, Regulatory Affairs Specialist, breaks down the nuances and details of each submission type to provide a comprehensive understanding that will empower you to navigate the FDA approval process and determine the optimal pathway for your product!

Mastering the distinctions between submission types is pivotal for a seamless and efficient journey to market success. Don't miss out on this valuable opportunity to expand your knowledge. Watch now!

Can't watch right now and rather read a quick summary? Here is a recap of what Joel shares in the video:

Hello, Joel. Here with the team at Proxima Clinical Research.

All new drugs and biologics that are developed by pharmaceutical companies must go through a rigorous process in an effort to get market approval by the FDA. To get this process started, a submission must be made by the developer. Which type of submission depends on multiple factors, such as the type of drug being developed, the intended use of the drug and the disease or condition being targeted.

Let's review the different types of drug submissions.

  1. First, we have the Investigational New Drug Application or IND. This submission is the first step for both drugs and biologics that are still in the investigational stage. The IND allows the FDA to review the preclinical data in support of a drug or biologic in order to establish that the product will not expose humans to unreasonable risks when used in clinical studies.
  2. Next, we have the New Drug Application or NDA. This is the most common type of drug submission for brand new drugs that have never been approved by the FDA before. It includes comprehensive data on the drug safety, efficacy and manufacturing, as well as results from clinical trials.
  3. Additionally, we have the Abbreviated New Drug Application or ANDA. This type of submission is for generic drugs that are intended to be equivalent to an already approved brand name drug. The ANDA includes data demonstrating that the generic drug is bio-equivalent to the brand name drug in terms of safety and effectiveness.
  4. Another type of submission is the Biologics License Application or BLA. This is for biological products such as vaccines and blood products that are made from blood proteins and living organisms. A BLA is a request for permission to introduce or deliver for introduction a biologic product into interstate commerce. The BLA includes data on safety, purity and potency of the product, as well as results from clinical trials.
  5. Next, we have the Over-The-Counter Drug Application or OTC. This is for drugs that are available without a prescription and can be purchased directly by consumers. There are two regulatory pathways to bring a nonprescription drug to market in the U.S.: the drug application process and the over-the-counter drug review or OTC monograph process.
  6. Lastly, we have the Drug Master File or DMF. This submission is not for a specific drug, but rather for confidential information about the drug's manufacturing, packaging or other aspects. The DMF is used as a reference by the FDA during the review of another drug submission, such as an NDA or ANDA. It's critical to understand the nuances between all submission types to form a strategy for your product’s approval path.

Fortunately, there's no need to do it alone. Ally yourself with the knowledgeable CRO like Proxima to make sure you're on the right track to get your product approved and on the market as early as possible. See the difference in Next-Gen CRO can make by visiting us at