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 · By Sanofi Admin

Drug Development 101: Applying for FDA Approval of Medications

FDAThis post was authored by Barry Sickels, Vice President, Regulatory Affairs at Sanofi US

The first two posts in our Drug Development 101 series provided insight into important elements of the drug development and approval process – Advisory Committee Meetings and the Prescription Drug User Fee Act (PDUFA). Both typically come into play after a drug application has been submitted to the US FDA. Today, though, we’re taking a step back to share some background on the multiple types of drug applications that can be submitted to the FDA. Did you know that there are different kinds?

You may have heard of New Drug Applications (NDAs), but those are actually just one of several types of applications that can be submitted – each with a unique purpose. Let’s examine them in more depth:

Investigational New Drug (IND): INDs are typically the first application that a company submits to the FDA for an investigational drug, since they clears the way for the drug’s administration to patients. In fact, in order to ship an investigational drug, the FDA requires an IND to be cleared. This is particularly important for clinical trials in which investigators across the country provide the potential new treatment to patients to help assess its safety and efficacy.

New Drug Application (NDA): Drug sponsors submit NDAs to obtain the FDA’s approval to market new drugs. An NDA is typically submitted once the drug’s sponsor has secured evidence to satisfy FDA’s requirements for the safety and efficacy of the drug. Essentially, an NDA tells the drug’s story and provides evidence demonstrating that its benefits outweigh its risks.

Abbreviated New Drug Application (ANDA): Generic drugs warrant a separate type of application, which is referred to as an “abbreviated” NDA, since preclinical and clinical data are not usually required. A generic drug sponsor typically needs to show the FDA that the drug performs the same way as the original brand-name version, or in more technical terms, they need to demonstrate therapeutic equivalence.

Biologic License Application (BLA): Biological products are a bit different from other drugs, as they are manufactured in living systems and have complex structures (check out this past Biologics 101 blog post to learn more). Biologics are also approved under the rules of the Public Health Service Act. As a result, they have their own distinct FDA application, which requires specific information about a product’s manufacturing process, chemistry, pharmacology, and more. The FDA review of a BLA generally follows the same process as for an NDA, and the BLA must also provide evidence that the benefits of the biological product outweigh the risks.

The regulatory process behind drug development and approval are complex, even when it comes to regulatory applications. However, it’s important to keep in mind that these applications are much more than just paperwork – they are critical documents that help the FDA better understand investigational drugs and support their intended use in patients.

To learn more, visit this application overview from the FDA. Stay tuned for the next edition of our Drug Development 101 series, as well.


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